Details of the SBP
| General Information of Synthetic Binding Protein (SBP) (ID: SBP000137) | ||||||
|---|---|---|---|---|---|---|
| SBP Name |
BiTE Blinatumomab
|
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| Synonyms |
AMG-103; AMG103; MT-103; Blincyto
|
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| Molecular Weight | 54.1 kDa | |||||
| Design Method | Traditional methods (Site-directed mutagenesis and/or Directed evolution) | |||||
| Expression System | Escherichia coli | |||||
| Highest Status | Marketed | |||||
| Sequence Length | 498 | |||||
| SBP Sequence |
>BiTE Blinatumomab
DIQLTQSPASLAVSLGQRATISCKASQSVDYDGDSYLNWYQQIPGQPPKLLIYDASNLVS GIPPRFSGSGSGTDFTLNIHPVEKVDAATYHCQQSTEDPWTFGGGTKLEIKGGGGSGGGG SGGGGSQVQLQQSGAELVRPGSSVKISCKASGYAFSSYWMNWVKQRPGQGLEWIGQIWPG DGDTNYNGKFKGKATLTADESSSTAYMQLSSLASEDSAVYFCARRETTTVGRYYYAMDYW GQGTTVTVSSGGGGSDIKLQQSGAELARPGASVKMSCKTSGYTFTRYTMHWVKQRPGQGL EWIGYINPSRGYTNYNQKFKDKATLTTDKSSSTAYMQLSSLTSEDSAVYYCARYYDDHYC LDYWGQGTTLTVSSVEGGSGGSGGSGGSGGVDDIQLTQSPAIMSASPGEKVTMTCRASSS VSYMNWYQQKSGTSPKRWIYDTSKVASGVPYRFSGSGSGTSYSLTISSMEAEDAATYYCQ QWSSNPLTFGAGTKLELK |
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| 3D Structure | ||||||
| Computationally Modelled Structure | ||||||
| Click to Save PDB File | ||||||
| Protein Scaffold Information of This SBP | ||||||
|---|---|---|---|---|---|---|
| Scaffold ID | PS018 | [1] , [2] , [3] | ||||
| Scaffold Name | BiTE | |||||
| Scaffold Class | Antibody fragment | |||||
| Fold Type | Beta-Sheets + Loops | |||||
| Binding Target(s) of This SBP (BTS) |
|---|
| BTS Name | Details | Mechanism | Application | Affinity | Research Organization | Ref |
|---|---|---|---|---|---|---|
| T-cell surface glycoprotein CD3 | Binder | Burkitt-like lymphoma with 11q aberration [ICD-11: XH8NN2] | N.A. | Micromet; Amgen | [1] , [2] , [3] | |
| B-lymphocyte antigen CD19 | Binder | Burkitt-like lymphoma with 11q aberration [ICD-11: XH8NN2] | N.A. | Micromet; Amgen | [1] , [2] , [3] | |
| Clinical Trial Information of This SBP | ||||||
|---|---|---|---|---|---|---|
| ACTRN12617000084381 | Click to show the Detail | |||||
| Indication | adult B-precursor Acute Lymphoblastic Leukaemia | |||||
| Phase | Phase II | |||||
| Title | BLAM-A phase IIb study of Blinatumomab + Cytarabine (AraC) and Methotrexate in adult B-precursor Acute Lymphoblastic Leukaemia | |||||
| Status | Recruiting | |||||
| Sponsor | Australasian Leukaemia and Lymphoma Group | |||||
| ACTRN12618001734257 | Click to show the Detail | |||||
| Indication | Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | ALL09-Phase II Study of Blinatumomab as Induction Therapy in Adolescent and Young Adult Acute Lymphoblastic Leukaemia | |||||
| Status | Recruiting | |||||
| Sponsor | Australasian Leukaemia and Lymphoma Group | |||||
| CTR20170176 | Click to show the Detail | |||||
| Indication | Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | An open label, multicenter, Phase III clinical study to evaluate the efficacy and safety of bite antibody blinatumomab in Chinese adult patients with relapsed / refractory(ALL) patients | |||||
| Status | Recruitment completed | |||||
| Sponsor | Amgen | |||||
| DRKS00003796 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | An Open Label, Multicenter, Exploratory Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab in Adult Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Completed | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| DRKS00003848 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | An Open Label, Multicenter, Phase II Study to Evaluate Efficacy and Safety of the BiTE Antibody Blinatumomab in Adult Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Recruiting | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| DRKS00005163 | Click to show the Detail | |||||
| Indication | B-precursor Acute Lymphoblastic Leukemia (BLAST) | |||||
| Phase | Phase II | |||||
| Title | A Confirmatory Multicenter, Single-arm Study to Assess the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab in Adult Patients With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (BLAST)-BLAST | |||||
| Status | Recruiting | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| DRKS00005727 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | A Phase III, Randomized, Open Label Study Investigating the Efficacy of the BiTE Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study) | |||||
| Status | Recruiting | |||||
| Sponsor | Amgen | |||||
| DRKS00010599 | Click to show the Detail | |||||
| Indication | HR First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | Phase III Trial to Investigate the Efficacy, Safety, and Tolerability of Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects With HR First Relapse B-precursor ALL | |||||
| Status | Recruiting | |||||
| Sponsor | Amgen | |||||
| EUCTR2009-015989-62-DE | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | An Open Label, Multicenter, Exploratory Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of the BiTE Antibody Blinatumomab in Adult Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)-MT103-206 | |||||
| Status | Not Recruiting | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| EUCTR2010-018314-75-DE | Click to show the Detail | |||||
| Indication | minimal residual disease (MRD) of B-precursor acute lymphoblastic leukemia | |||||
| Phase | Phase II | |||||
| Title | A confirmatory multicenter, single-arm study to assess the efficacy, safety, and tolerability of the BiTE? antibody blinatumomab in adult patients with minimal residual disease (MRD) of B-precursor acute lymphoblastic leukemia-BLAST MT103-203 | |||||
| Status | Authorised | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| EUCTR2010-018314-75-ES | Click to show the Detail | |||||
| Indication | B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | Estudio multicntrico confirmatorio de brazo nico para evaluar la eficacia, seguridad y tolerabilidad del anticuerpo BiTE? conocido como blinatumomab en pacientes adultos con enfermedad mnima residual (EMR) de leucemia linfoblstica aguda de precursores B (A confirmatory multicenter, single-arm study to assess the efficacy, safety, and tolerability of the BiTE? antibody blinatumomab in adult patients with minimal residual disease (MRD) of B-precursor acute lymphoblastic leukemia)-MT103-203 | |||||
| Status | Not Recruiting | |||||
| Sponsor | Micromet AG | |||||
| EUCTR2010-024264-18-AT | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase I; Phase II | |||||
| Title | A Single-Arm Multicenter Phase II Study preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Not Recruiting | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| EUCTR2010-024264-18-DE | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase I; Phase II | |||||
| Title | A Single-Arm Multicenter Phase II Study preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Not Recruiting | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| EUCTR2010-024264-18-GB | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase I; Phase II | |||||
| Title | A Single-Arm Multicenter Phase II Study preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Not Recruiting | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| EUCTR2010-024264-18-IT | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Not Applicable | |||||
| Title | A Single-Arm Multicenter Phase II Study preceded by Dose Evalua-tion to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Not Recruiting | |||||
| Sponsor | MICROMET GMBH | |||||
| EUCTR2010-024264-18-NL | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase I; Phase II | |||||
| Title | A Single-Arm Multicenter Phase II Study preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Not Recruiting | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| EUCTR2010-024264-18-Outside-EU/EEA | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | A Single-Arm Multicenter Phase II Study preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Not Available | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| EUCTR2011-002257-61-DE | Click to show the Detail | |||||
| Indication | relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | An open label, multicenter, phase II study to evaluate efficacy and safety of the BiTE antibody blinatumomab in adult patients with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) | |||||
| Status | Not Recruiting | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| EUCTR2011-002257-61-ES | Click to show the Detail | |||||
| Indication | relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | An open label, multicenter, phase II study to evaluate efficacy and safety of the BiTE antibody blinatumomab in adult patients with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) | |||||
| Status | Not Recruiting | |||||
| Sponsor | . | |||||
| EUCTR2011-002257-61-GB | Click to show the Detail | |||||
| Indication | relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | An open label, multicenter, phase II study to evaluate efficacy and safety of the BiTE antibody blinatumomab in adult patients with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) | |||||
| Status | Not Recruiting | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| EUCTR2011-002257-61-IT | Click to show the Detail | |||||
| Indication | relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | An open label, multicenter, phase II study to evaluate efficacy and safety of the BiTE antibody blinatumomab in adult patients with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) | |||||
| Status | Not Recruiting | |||||
| Sponsor | MICROMET AG | |||||
| EUCTR2011-005781-38-DE | Click to show the Detail | |||||
| Indication | Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | |||||
| Phase | Phase II | |||||
| Title | An Open Label, Multicenter, Exploratory Phase II Study to Evaluate the Efficacy and Safety of the Bispecific T-Cell Engager (BiTE) Blinatumomab in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | |||||
| Status | Not Recruiting | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| EUCTR2013-000536-10-IT | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | A Phase III, Randomized, Open Label Study Investigating the Efficacy of the BiTE? Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study)-TOWER Study | |||||
| Status | Not Recruiting | |||||
| Sponsor | Amgen | |||||
| EUCTR2013-000706-36-DE | Click to show the Detail | |||||
| Indication | Relapsed or Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | A Phase II Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE? Antibody Blinatumomab in Adult Subjects with Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (Alcantara Study)-Alcantara Study | |||||
| Status | Not Recruiting | |||||
| Sponsor | Amgen | |||||
| EUCTR2013-000706-36-GB | Click to show the Detail | |||||
| Indication | Relapsed or Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | A Phase II Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE? Antibody Blinatumomab in Adult Subjects with Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (Alcantara Study)-Alcantara Study | |||||
| Status | Not Recruiting | |||||
| Sponsor | Amgen | |||||
| EUCTR2013-000706-36-IT | Click to show the Detail | |||||
| Indication | Relapsed or Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | A Phase II Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE? Antibody Blinatumomab in Adult Subjects with Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (Alcantara Study)-Alcantara Study | |||||
| Status | Authorised | |||||
| Sponsor | Amgen | |||||
| EUCTR2014-002476-92-BE | Click to show the Detail | |||||
| Indication | High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | A Randomized, Open-label, Controlled Phase III Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Authorised | |||||
| Sponsor | Amgen | |||||
| EUCTR2014-002476-92-CZ | Click to show the Detail | |||||
| Indication | High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | A Randomized, Open-label, Controlled Phase III Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Authorised | |||||
| Sponsor | Amgen | |||||
| EUCTR2014-002476-92-DK | Click to show the Detail | |||||
| Indication | High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | A Randomized, Open-label, Controlled Phase III Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Authorised | |||||
| Sponsor | Amgen | |||||
| EUCTR2014-002476-92-ES | Click to show the Detail | |||||
| Indication | High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | A Randomized, Open-label, Controlled Phase III Adaptive Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Authorised | |||||
| Sponsor | Amgen | |||||
| EUCTR2014-002476-92-FR | Click to show the Detail | |||||
| Indication | High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | A Randomized, Open-label, Controlled Phase III Adaptive Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Authorised | |||||
| Sponsor | Amgen | |||||
| EUCTR2014-002476-92-GB | Click to show the Detail | |||||
| Indication | High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | A Randomized, Open-label, Controlled Phase III Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Not Available | |||||
| Sponsor | Amgen | |||||
| EUCTR2014-002476-92-GR | Click to show the Detail | |||||
| Indication | High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | A Randomized, Open-label, Controlled Phase III Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Not Recruiting | |||||
| Sponsor | Amgen | |||||
| EUCTR2014-002476-92-IT | Click to show the Detail | |||||
| Indication | High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | A Randomized, Open-label, Controlled Phase III Adaptive Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Authorised | |||||
| Sponsor | Amgen | |||||
| EUCTR2014-002476-92-NL | Click to show the Detail | |||||
| Indication | High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | A Randomized, Open-label, Controlled Phase III Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Authorised | |||||
| Sponsor | Amgen | |||||
| EUCTR2014-002476-92-NO | Click to show the Detail | |||||
| Indication | High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | A Randomized, Open-label, Controlled Phase III Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Not Recruiting | |||||
| Sponsor | Amgen | |||||
| EUCTR2014-002476-92-Outside-EU/EEA | Click to show the Detail | |||||
| Indication | High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | A Randomized, Open-label, Controlled Phase III Adaptive Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Not Available | |||||
| Sponsor | Amgen | |||||
| EUCTR2014-002476-92-PL | Click to show the Detail | |||||
| Indication | High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | A Randomized, Open-label, Controlled Phase III Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Authorised | |||||
| Sponsor | Amgen | |||||
| EUCTR2014-002476-92-PT | Click to show the Detail | |||||
| Indication | High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | A Randomized, Open-label, Controlled Phase III Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Authorised | |||||
| Sponsor | Amgen | |||||
| EUCTR2014-002476-92-SE | Click to show the Detail | |||||
| Indication | High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | A Randomized, Open-label, Controlled Phase III Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Not Recruiting | |||||
| Sponsor | Amgen | |||||
| EUCTR2015-000733-76-DE | Click to show the Detail | |||||
| Indication | minimal residual disease (MRD) of B-precursor acute lympho-blastic leukemia | |||||
| Phase | Phase II | |||||
| Title | A multicenter, single-arm study to assess the efficacy, safety, and tolerability of the BiTE? antibody blinatumomab in adult patients with minimal residual disease (MRD) of B-precursor acute lympho-blastic leukemia (Blast Successor Trial) | |||||
| Status | Authorised | |||||
| Sponsor | Goethe-Universit?t Frankfurt, Universit?tsklinikum, Med. Klinik II | |||||
| EUCTR2016-002044-16-GB | Click to show the Detail | |||||
| Indication | Relapsed or Refractory Aggressive B-Cell Non Hodgkin Lymphoma | |||||
| Phase | Phase II; Phase III | |||||
| Title | A Phase II/3 Multi-center Study of Evaluate the Safety and Efficacy of Blinatumomab in Subjects with Relapsed/Refractory Aggressive B-Cell Non Hodgkin Lymphoma | |||||
| Status | Not Recruiting | |||||
| Sponsor | Amgen | |||||
| EUCTR2016-002190-35-DE | Click to show the Detail | |||||
| Indication | High-risk Diffuse Large B-Cell Lymphoma (DLBCL) | |||||
| Phase | Phase II | |||||
| Title | A Phase II Open-label Study Investigating the Safety and Efficacy of Blinatumomab After Frontline R-Chemotherapy in Adult Subjects With Newly Diagnosed High-risk Diffuse Large B-Cell Lymphoma (DLBCL) | |||||
| Status | Not Recruiting | |||||
| Sponsor | Amgen | |||||
| EUCTR2016-002190-35-ES | Click to show the Detail | |||||
| Indication | High-risk Diffuse Large B-Cell Lymphoma (DLBCL) | |||||
| Phase | Phase II | |||||
| Title | A Phase II Open-label Study Investigating the Safety and Efficacy of Blinatumomab After Frontline R-Chemotherapy in Adult Subjects With Newly Diagnosed High-risk Diffuse Large B-Cell Lymphoma (DLBCL) | |||||
| Status | Not Recruiting | |||||
| Sponsor | Amgen | |||||
| EUCTR2016-002190-35-FR | Click to show the Detail | |||||
| Indication | High-risk Diffuse Large B-Cell Lymphoma (DLBCL) | |||||
| Phase | Phase II | |||||
| Title | A Phase II Open-label Study Investigating the Safety and Efficacy of Blinatumomab After Frontline R-Chemotherapy in Adult Subjects With Newly Diagnosed High-risk Diffuse Large B-Cell Lymphoma (DLBCL) | |||||
| Status | Authorised | |||||
| Sponsor | Amgen | |||||
| EUCTR2016-002190-35-GB | Click to show the Detail | |||||
| Indication | High-risk Diffuse Large B-Cell Lymphoma (DLBCL) | |||||
| Phase | Phase II | |||||
| Title | A Phase II Open-label Study Investigating the Safety and Efficacy of Blinatumomab After Frontline R-Chemotherapy in Adult Subjects With Newly Diagnosed High-risk Diffuse Large B-Cell Lymphoma (DLBCL) | |||||
| Status | Authorised | |||||
| Sponsor | Amgen | |||||
| EUCTR2016-002372-27-HU | Click to show the Detail | |||||
| Indication | Pediatric patient | |||||
| Phase | Phase IV | |||||
| Title | Administration of blinatumomab to one pediatric patient | |||||
| Status | Authorised | |||||
| Sponsor | BAZ Megyei s Egyetemi Oktat Krhz | |||||
| EUCTR2016-003255-30-GR | Click to show the Detail | |||||
| Indication | High-risk Diffuse Large B-Cell Lymphoma (DLBCL) Post-autologous Hematopoietic Stem-cell Transplantation | |||||
| Phase | Phase II | |||||
| Title | A Phase II Open-Label Study to Determine the Effect of Blinatumomab on Minimal Residual Disease in Subjects With High-risk Diffuse Large B-Cell Lymphoma Post-autologous Hematopoietic Stem-cell Transplantation | |||||
| Status | Not Recruiting | |||||
| Sponsor | Amgen Inc | |||||
| EUCTR2016-004877-42-ES | Click to show the Detail | |||||
| Indication | high-risk Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukaemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | A phase II, open-label study to evaluate the effect of blinatumomab administered during consolidation to reduce the level of minimal residual disease (MRD) assessed through flow cytometry in adult patients up to 55 years of age with high-risk Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukaemia (ALL) with good response (MRD < 0.1%) after induction therapy | |||||
| Status | Authorised | |||||
| Sponsor | FUNDACIN PETHEMA | |||||
| EUCTR2017-002314-31-DE | Click to show the Detail | |||||
| Indication | Treatment-Resistant Mixed Chimerism or Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia after Allogeneic Stem Cell | |||||
| Phase | Phase II | |||||
| Title | Phase II Study Evaluating the Safety, Tolerability and Efficacy of Allogeneic Donor Lymphocyte Infusions Combined with Blinatumomab in Patients with Treatment-Resistant Mixed Chimerism or Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia after Allogeneic Stem Cell Transplantation-DLI-TARGET | |||||
| Status | Not Recruiting | |||||
| Sponsor | Klinikum der Universit?t Mnchen | |||||
| EUCTR2017-002853-13-DE | Click to show the Detail | |||||
| Indication | CD19 positive, Ph or BCR-ABL negative B-precursor acute lymphoblastic leukemia | |||||
| Phase | Phase II | |||||
| Title | Phase II trial for the treatment of older patients with newly diagnosed CD19 positive, Ph/BCR-ABL negative B-precursor acute lymphoblastic leukemia with sequential dose reduced chemotherapy and Blinatumomab (EWALL-BOLD)-EWALL-BOLD | |||||
| Status | Authorised | |||||
| Sponsor | Goethe Universit?t Frankfurt | |||||
| EUCTR2017-004577-14-CZ | Click to show the Detail | |||||
| Indication | minimal residual disease (MRD) in bone | |||||
| Phase | Phase II | |||||
| Title | Single cycle of blinatumomab followed by high-dose chemotherapy in the induction therapy for Ph-negative acute lymphoblastic leukemia in adults.-Blina-CELL | |||||
| Status | Authorised | |||||
| Sponsor | Ustav hematologie a krevni transfuze | |||||
| EUCTR2018-003350-25-GB | Click to show the Detail | |||||
| Indication | Philadelphia chromosome positive (Ph+ or BCR-ABL+) acute lymphoblastic leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | An open label, 3-arm, Randomised phase II study to Compare the Safety and Efficacy of Ponatinib in combination with either Chemotherapy or Blinatumomab with Imatinib plus Chemotherapy as front-line therapy for patients aged 55 years and over with Philadelphia chromosome positive (Ph+ or BCR-ABL+) acute lymphoblastic leukemia (ALL)-EWALL-Ph-03 | |||||
| Status | Authorised | |||||
| Sponsor | Cardiff University | |||||
| EUCTR2018-003483-32-FR | Click to show the Detail | |||||
| Indication | Richter Transformation | |||||
| Phase | Phase II | |||||
| Title | BLINAtumomab after R-CHOP debulking therapy for patients with Richter Transformation.-FILOCLL13-BLINART | |||||
| Status | Authorised | |||||
| Sponsor | FILO | |||||
| NCT00274742 | Click to show the Detail | |||||
| Indication | Relapsed Non-Hodgkin's Lymphoma (NHL) | |||||
| Phase | Phase I | |||||
| Title | An Open-label, Multi-center Phase I Study to Investigate the Tolerability and Safety of a Continuous Infusion of the Bispecific T-cell Engager?MT103?in Patients With Relapsed Non-Hodgkin's Lymphoma (NHL) | |||||
| Status | Completed | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| NCT00560794 | Click to show the Detail | |||||
| Indication | B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | Open-label, Multicenter Phase II Study to Investigate the Efficacy, Safety, and Tolerability of the Bispecific T-cell Engager (BiTE?) MT103 in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia | |||||
| Status | Completed | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| NCT01207388 | Click to show the Detail | |||||
| Indication | B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | A Confirmatory Multicenter, Single-arm Study to Assess the Efficacy, Safety, and Tolerability of the BiTE? Antibody?Blinatumomab?in Adult Patients With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (BLAST) | |||||
| Status | Completed | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| NCT01209286 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | An Open Label, Multicenter, Exploratory Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of the BiTE? Antibody Blinatumomab in Adult Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Completed | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| NCT01466179 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | An Open Label, Multicenter, Phase II Study to Evaluate Efficacy and Safety of the BiTE? Antibody?Blinatumomab?in Adult Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Completed | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| NCT01471782 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase I; Phase II | |||||
| Title | A Single-Arm Multicenter Phase II Study Preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE? Antibody?Blinatumomab?(MT103) in Pediatric and Adolescent Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Completed | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| NCT01741792 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | |||||
| Phase | Phase II | |||||
| Title | An Open Label, Multicenter, Exploratory Phase II Study to Evaluate the Efficacy and Safety of the Bispecific T-Cell Engager (BiTE?)?Blinatumomab?in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | |||||
| Status | Completed | |||||
| Sponsor | Amgen Research (Munich) GmbH | |||||
| NCT02000427 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | A Phase II Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE Antibody?Blinatumomab?in Adult Subjects With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (Alcantara Study) | |||||
| Status | Completed | |||||
| Sponsor | Amgen | |||||
| NCT02003222 | Click to show the Detail | |||||
| Indication | Acute Lymphoblastic Leukemia (ALL); B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative | |||||
| Phase | Phase III | |||||
| Title | A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults | |||||
| Status | Active, not recruiting | |||||
| Sponsor | National Cancer Institute (NCI) | |||||
| NCT02013167 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | A Phase III, Randomized, Open Label Study Investigating the Efficacy of the BiTE Antibody?Blinatumomab?Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study) | |||||
| Status | Terminated | |||||
| Sponsor | Amgen | |||||
| NCT02101853 | Click to show the Detail | |||||
| Indication | First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL) | |||||
| Phase | Phase III | |||||
| Title | Risk-Stratified Randomized Phase III Testing of?Blinatumomab?(NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL) | |||||
| Status | Active, not recruiting | |||||
| Sponsor | National Cancer Institute (NCI) | |||||
| NCT02143414 | Click to show the Detail | |||||
| Indication | Acute Lymphoblastic Leukemia (ALL); Dasatinib-Sensitive Mutations or Kinase Fusions (DSMKF) | |||||
| Phase | Phase II | |||||
| Title | A Phase II Study of?Blinatumomab?and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients > /= 65 Years of Age With Newly Diagnosed Philadelphia-Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (ALL) and of Dasatinib, Prednisone and?Blinatumomab?for Patients > /= 65 Years of Age With Newly Diagnosed Philadelphia-Chromosome Positive (Ph+) ALL, Relapsed/Refractory Philadelphia-Chromosome Positive (Ph+) ALL, and Philadelphia-Chromosome-Like Signature (Ph-Like) ALL With Known or Presumed Activating Dasatinib-Sensitive Mutations or Kinase Fusions (DSMKF) | |||||
| Status | Recruiting | |||||
| Sponsor | National Cancer Institute (NCI) | |||||
| NCT02187354 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | An Open-Label, Multi-center, Expanded Access Protocol of?Blinatumomab?for the Treatment of Pediatric and Adolescent Subjects With Relapsed and/or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Not Available | |||||
| Sponsor | Amgen | |||||
| NCT02393859 | Click to show the Detail | |||||
| Indication | B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | Phase III Trial to Investigate the Efficacy, Safety, and Tolerability of Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects With HR First Relapse B-precursor ALL | |||||
| Status | Active, not recruiting | |||||
| Sponsor | Amgen | |||||
| NCT02412306 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase I; Phase II | |||||
| Title | A Phase Ib/2 Study of?Blinatumomab?in Japanese Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (Horai Study) | |||||
| Status | Completed | |||||
| Sponsor | Amgen | |||||
| NCT02458014 | Click to show the Detail | |||||
| Indication | Positive Minimal Residual Disease | |||||
| Phase | Phase II | |||||
| Title | Phase II Study of?Blinatumomab?in Patients With B-Cell Lineage Acute Lymphocytic Leukemia With Positive Minimal Residual Disease | |||||
| Status | Recruiting | |||||
| Sponsor | M.D. Anderson Cancer Center | |||||
| NCT02568553 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory Non-Hodgkins Lymphoma (NHL) | |||||
| Phase | Phase I | |||||
| Title | A Phase I Trial of the Combination of Lenalidomide and?Blinatumomab?in Patients With Relapsed or Refractory Non-Hodgkins Lymphoma (NHL) | |||||
| Status | Recruiting | |||||
| Sponsor | National Cancer Institute (NCI) | |||||
| NCT02744768 | Click to show the Detail | |||||
| Indication | Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | D-ALBA Front-Line Sequential Treatment of Adult Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Patients With Dasatinib and the Bispecific Monoclonal Antibody?Blinatumomab | |||||
| Status | Recruiting | |||||
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto | |||||
| NCT02790515 | Click to show the Detail | |||||
| Indication | Acute Lymphoblastic Leukemia (ALL); Acute Myeloid Leukemia (AML); Myeloid Sarcoma; Chronic Myeloid Leukemia (CML); Juvenile Myelomonocytic Leukemia (JMML); Myelodysplastic Syndrome (MDS); Non-Hodgkin Lymphoma (NHL) | |||||
| Phase | Phase II | |||||
| Title | Provision of TCRgamma delta T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Na?ve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation | |||||
| Status | Recruiting | |||||
| Sponsor | St. Jude Children's Research Hospital | |||||
| NCT02807883 | Click to show the Detail | |||||
| Indication | Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | Blinatumomab?Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia | |||||
| Status | Recruiting | |||||
| Sponsor | M.D. Anderson Cancer Center | |||||
| NCT02811679 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory Indolent Non-Hodgkin Lymphoma (NHL) | |||||
| Phase | Phase II | |||||
| Title | A Phase II Study Of?Blinatumomab?For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma | |||||
| Status | Recruiting | |||||
| Sponsor | Massachusetts General Hospital | |||||
| NCT02877303 | Click to show the Detail | |||||
| Indication | B-Cell Lineage Acute Lymphocytic Leukemia | |||||
| Phase | Phase II | |||||
| Title | Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With?Blinatumomab?as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia | |||||
| Status | Recruiting | |||||
| Sponsor | M.D. Anderson Cancer Center | |||||
| NCT02879695 | Click to show the Detail | |||||
| Indication | Poor-Risk, Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia | |||||
| Phase | Phase I | |||||
| Title | A Phase I Study of?Blinatumomab?in Combination With Checkpoint Inhibitor(s) of PD-1 (Nivolumab) or Both PD-1 (Nivolumab) and CTLA-4 (Ipilimumab) in Patients With Poor-Risk, Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia | |||||
| Status | Recruiting | |||||
| Sponsor | National Cancer Institute (NCI) | |||||
| NCT02910063 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory Aggressive B-Cell Non Hodgkin Lymphoma (NHL) | |||||
| Phase | Phase II | |||||
| Title | A Phase II/3 Multi-center Study to Evaluate the Safety and Efficacy of?Blinatumomab?in Subjects With Relapsed/Refractory Aggressive B-Cell Non Hodgkin Lymphoma | |||||
| Status | Completed | |||||
| Sponsor | Amgen | |||||
| NCT02961881 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma (NHL) | |||||
| Phase | Phase I | |||||
| Title | A Phase Ib Open-Label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous?Blinatumomab?for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma | |||||
| Status | Recruiting | |||||
| Sponsor | Amgen | |||||
| NCT02997761 | Click to show the Detail | |||||
| Indication | Relapsed and Refractory B-Cell Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | A Phase II Study of Ibrutinib and?Blinatumomab?in Relapsed and Refractory B-Cell Acute Lymphoblastic Leukemia | |||||
| Status | Recruiting | |||||
| Sponsor | Brian Jonas | |||||
| NCT03023878 | Click to show the Detail | |||||
| Indication | High-risk Diffuse Large B-Cell Lymphoma (DLBCL) | |||||
| Phase | Phase II | |||||
| Title | 20150288 A Phase II Open-label Study Investigating the Safety and Efficacy of?Blinatumomab?After Frontline R-Chemotherapy in Adult Subjects With Newly Diagnosed High-risk Diffuse Large B-Cell Lymphoma (DLBCL) | |||||
| Status | Completed | |||||
| Sponsor | Amgen | |||||
| NCT03072771 | Click to show the Detail | |||||
| Indication | Diffuse Large B-Cell Lymphoma (DLBCL) | |||||
| Phase | Phase I | |||||
| Title | A Pilot Trial of?Blinatumomab?Consolidation Post Autologous Stem Cell Transplantation in Patients With DLBCL | |||||
| Status | Recruiting | |||||
| Sponsor | Washington University School of Medicine | |||||
| NCT03109093 | Click to show the Detail | |||||
| Indication | B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | A Multicenter, Single-arm Study to Assess the Efficacy, Safety, and Tolerability of the BiTE? Antibody?Blinatumomab?in Adult Patients With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (Blast Successor Trial) | |||||
| Status | Recruiting | |||||
| Sponsor | Goethe University | |||||
| NCT03114865 | Click to show the Detail | |||||
| Indication | Pre B-cell Acute Lymphoblastic Leukemia (ALL); B-cell Non-Hodgkin Lymphoma (NHL) | |||||
| Phase | Phase I; Phase II | |||||
| Title | A Phase IB/II Study of Blinatumomab in Patients With Pre B-cell Acute Lymphoblastic Leukemia (ALL) and B-cell Non-Hodgkin Lymphoma (NHL) as Post-allogeneic Stem Cell Transplant (Allo-HSCT) Remission Maintenance | |||||
| Status | Recruiting | |||||
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||||
| NCT03117621 | Click to show the Detail | |||||
| Indication | Blincyto?Use in Routine Clinical Practice | |||||
| Phase | . | |||||
| Title | An Observational Study of?Blinatumomab?Safety and Effectiveness, Utilization, and Treatment Practices | |||||
| Status | Recruiting | |||||
| Sponsor | Amgen | |||||
| NCT03117751 | Click to show the Detail | |||||
| Indication | Acute Lymphoblastic Leukemia (ALL); Lymphoma | |||||
| Phase | Phase II; Phase III | |||||
| Title | Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma | |||||
| Status | Recruiting | |||||
| Sponsor | St. Jude Children's Research Hospital | |||||
| NCT03121534 | Click to show the Detail | |||||
| Indication | Richter Transformation | |||||
| Phase | Phase II | |||||
| Title | A Phase II Study of Blinatumomab in Richter Transformation | |||||
| Status | Active, not recruiting | |||||
| Sponsor | M.D. Anderson Cancer Center | |||||
| NCT03147612 | Click to show the Detail | |||||
| Indication | Philadelphia Chromosome-Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | Phase II Study of the Sequential Combination of Low-Intensity Chemotherapy and Ponatinib Followed by?Blinatumomab?and Ponatinib in Patients With Philadelphia Chromosome (Ph)-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Recruiting | |||||
| Sponsor | M.D. Anderson Cancer Center | |||||
| NCT03160079 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-lineage Acute Lymphoblastic Leukemia With High Bone Marrow Lymphoblast Percentage | |||||
| Phase | Phase I; Phase II | |||||
| Title | A Phase I/II Study of?Blinatumomab?in Combination With Pembrolizumab (MK-3475) for Adults With Relapsed or Refractory B-lineage Acute Lymphoblastic Leukemia With High Bone Marrow Lymphoblast Percentage | |||||
| Status | Recruiting | |||||
| Sponsor | Matthew Wieduwilt, M.D., Ph.D. | |||||
| NCT03173430 | Click to show the Detail | |||||
| Indication | Refractory Multiple Myeloma | |||||
| Phase | Phase I | |||||
| Title | Pilot Study of?Blinatumomab?in Combination With Salvage Autologous Stem Cell Transplantation for Patients With Refractory Multiple Myeloma | |||||
| Status | Terminated?(Slow Accrual) | |||||
| Sponsor | Abramson Cancer Center of the University of Pennsylvania | |||||
| NCT03263572 | Click to show the Detail | |||||
| Indication | Philadelphia Chromosome-Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | Phase II Study of the Combination of?Blinatumomab?and Ponatinib in Patients With Philadelphia Chromosome (Ph)-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Recruiting | |||||
| Sponsor | M.D. Anderson Cancer Center | |||||
| NCT03298412 | Click to show the Detail | |||||
| Indication | High-risk Diffuse Large B-Cell Lymphoma (DLBCL) Post-autologous Hematopoietic Stem-cell Transplantation | |||||
| Phase | Phase II | |||||
| Title | A Phase II Open-Label Study to Determine the Effect of?Blinatumomab?on Minimal Residual Disease in Subjects With High-risk Diffuse Large B-cell Lymphoma Post-autologous Hematopoietic Stem-cell Transplantation. | |||||
| Status | Terminated?(Rare Patient Population) | |||||
| Sponsor | Amgen | |||||
| NCT03318770 | Click to show the Detail | |||||
| Indication | Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | . | |||||
| Title | Ancillary Observational Study of Post-Frontline Sequential Treatment of Adult Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Patients With Dasatinib and the Bispecific Monoclonal Antibody?Blinatumomab | |||||
| Status | Not recruiting | |||||
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto | |||||
| NCT03340766 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | |||||
| Phase | Phase I | |||||
| Title | A Phase Ib Open Label Study Investigating the Safety and Efficacy of?Blinatumomab?in Combination With Pembrolizumab in Adult Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (KEYNOTE-348) | |||||
| Status | Recruiting | |||||
| Sponsor | Amgen | |||||
| NCT03367299 | Click to show the Detail | |||||
| Indication | Philadelphia Chromosome-Negative B-Cell Precursor Adult Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | National Treatment Program With Sequential Chemotherapy and?Blinatumomab?to Improve Minimal Residual Disease Response and Survival in Philadelphia Chromosome-Negative B-Cell Precursor Adult Acute Lymphoblastic Leukemia | |||||
| Status | Recruiting | |||||
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto | |||||
| NCT03476239 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | An Open-label, Multicenter, Phase III Study to Evaluate Efficacy and Safety of the BiTE Antibody Blinatumomab in Chinese Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Active, not recruiting | |||||
| Sponsor | Amgen | |||||
| NCT03480438 | Click to show the Detail | |||||
| Indication | B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | Phase II Trial for the Treatment of Older Patients With Newly Diagnosed CD19 Positive, Ph/BCR-ABL Negative B-precursor Acute Lymphoblastic Leukemia With Sequential Dose Reduced Chemotherapy and?Blinatumomab?(EWALL-BOLD) | |||||
| Status | Recruiting | |||||
| Sponsor | Goethe University | |||||
| NCT03512405 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory Acute Lymphoblastic Leukemia | |||||
| Phase | Phase I; Phase II | |||||
| Title | A Phase I/2 Trial of Pembrolizumab in Combination With?Blinatumomab?in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia | |||||
| Status | Recruiting | |||||
| Sponsor | City of Hope Medical Center | |||||
| NCT03518112 | Click to show the Detail | |||||
| Indication | Philadelphia Chromosome Negative Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | Phase II Study of the Combination of Low-Intensity Chemotherapy and?Blinatumomab?in Patients With Philadelphia Chromosome Negative Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Recruiting | |||||
| Sponsor | M.D. Anderson Cancer Center | |||||
| NCT03523429 | Click to show the Detail | |||||
| Indication | High-risk Philadelphia Chromosome-negative (Ph-) Acute Lymphoblastic Leukaemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | A Phase II, Open-label Study to Evaluate the Effect of Blinatumomab Administered During Consolidation to Reduce the Level of Minimal Residual Disease (MRD) Assessed Through Flow Cytometry in Adult Patients up to 55 Years of Age With High-risk Philadelphia Chromosome-negative (Ph-) Acute Lymphoblastic Leukaemia (ALL) With Good Response (MRD < 0.1%) After Induction Therapy | |||||
| Status | Recruiting | |||||
| Sponsor | PETHEMA Foundation | |||||
| NCT03541083 | Click to show the Detail | |||||
| Indication | B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | Blinatumomab?Added to Prephase and Consolidation Therapy in Precursor B-acute Lymphoblastic Leukemia in Adults. A Phase II Trial | |||||
| Status | Recruiting | |||||
| Sponsor | Stichting Hemato-Oncologie voor Volwassenen Nederland | |||||
| NCT03605589 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory CD19 Positive B-cell Acute Leukemia or Lymphoma | |||||
| Phase | Phase I | |||||
| Title | A Pilot Study of?Blinatumomab?in Combination With a PD1 Inhibitor, Pembrolizumab, in Pediatric and Young Adult Patients With Relapsed/Refractory CD19 Positive B-cell Acute Leukemia or Lymphoma | |||||
| Status | Suspended?(Slow Recruitment) | |||||
| Sponsor | Children's Hospital Medical Center, Cincinnati | |||||
| NCT03628053 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | Tisagenlecleucel Versus Blinatumomab or Inotuzumab for Adult Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia: A Randomized Open Label, Multicenter, Phase III Trial | |||||
| Status | Withdrawn?(Novartis is no longer pursuing this study because of planned investigation of novel CAR-T therapies in this patient population.) | |||||
| Sponsor | Novartis Pharmaceuticals | |||||
| NCT03643276 | Click to show the Detail | |||||
| Indication | Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | International Collaborative Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia-AIEOP-BFM ALL 2017 | |||||
| Status | Recruiting | |||||
| Sponsor | Martin Schrappe | |||||
| NCT03709719 | Click to show the Detail | |||||
| Indication | High-risk B-cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL) | |||||
| Phase | Phase II | |||||
| Title | A Phase II Study to Evaluate the Safety and the Efficacy of a Blinatumomab Based Consolidation and Maintenance in Patients With High-risk B-cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL). GRAALL-QUEST | |||||
| Status | Recruiting | |||||
| Sponsor | Assistance Publique-H?pitaux de Paris | |||||
| NCT03739814 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory Disease | |||||
| Phase | Phase II | |||||
| Title | A Phase II Study of Inotuzumab Ozogamicin Followed by?Blinatumomab?for Ph-Negative CD22-Positive B-Lineage Acute Lymphoblastic Leukemia in Newly Diagnosed Older Adults or Adults With Relapsed or Refractory Disease | |||||
| Status | Recruiting | |||||
| Sponsor | National Cancer Institute (NCI) | |||||
| NCT03751072 | Click to show the Detail | |||||
| Indication | B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | . | |||||
| Title | Efficacy and Toxicity of?Blinatumomab?in the French Compassionate Use Program (ATU) for Adult Patients With B-cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL) Refractory, in Relapse, or With Positive Minimal Residual Disease. | |||||
| Status | Unknown | |||||
| Sponsor | Group for Research in Adult Acute Lymphoblastic Leukemia | |||||
| NCT03751709 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase I | |||||
| Title | IIT2017-05-MERIN-BLINHMCT:?Blinatumomab?Plus HLA-Mismatched Cellular Therapy (HMCT) for Relapsed/Refractory CD19+ ALL | |||||
| Status | Recruiting | |||||
| Sponsor | Cedars-Sinai Medical Center | |||||
| NCT03823365 | Click to show the Detail | |||||
| Indication | Indolent Non-Hodgkin Lymphomas or Chronic Lymphocytic Leukemia | |||||
| Phase | Phase I | |||||
| Title | Immune Reconstitution With?Blinatumomab?Expanded T-cells (BET) After First-line Treatment With Fludarabine-Cyclophosphamide-Rituximab or Bendamustine-Rituximab in CD20+ Indolent Non-Hodgkin Lymphomas/Chronic Lymphocytic Leukemia: a Phase I Study | |||||
| Status | Recruiting | |||||
| Sponsor | A.O. Ospedale Papa Giovanni XXIII | |||||
| NCT03849651 | Click to show the Detail | |||||
| Indication | Acute Lymphoblastic Leukemia (ALL); Acute Myeloid Leukemia (AML); Myelodysplastic Syndromes (MDS); NK-Cell Leukemia; Hodgkin Lymphoma; Non Hodgkin Lymphoma (NHL); Juvenile Myelomonocytic Leukemia (JMML); Chronic Myeloid Leukemia (CML) | |||||
| Phase | Phase II | |||||
| Title | TCRalphabeta-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies | |||||
| Status | Recruiting | |||||
| Sponsor | St. Jude Children's Research Hospital | |||||
| NCT03914625 | Click to show the Detail | |||||
| Indication | B-Lymphoblastic Leukemia (B-ALL); Localized B-Lymphoblastic Lymphoma (B-LLy) | |||||
| Phase | Phase III | |||||
| Title | A Phase III Trial Investigating Blinatumomab (NSC# 765986) in Combination With Chemotherapy in Patients With Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients With Localized B-Lymphoblastic Lymphoma (B-LLy) | |||||
| Status | Recruiting | |||||
| Sponsor | National Cancer Institute (NCI) | |||||
| NCT03931642 | Click to show the Detail | |||||
| Indication | Richter Transformation | |||||
| Phase | Phase II | |||||
| Title | BLINAtumomab?After R-CHOP Debulking Therapy for Patients With Richter Transformation | |||||
| Status | Recruiting | |||||
| Sponsor | French Innovative Leukemia Organisation | |||||
| NCT03982992 | Click to show the Detail | |||||
| Indication | B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | Phase II Study Evaluating the Safety, Tolerability and Efficacy of Allogeneic Donor Lymphocyte Infusions Combined With?Blinatumomab?in Patients With Treatment-Resistant Mixed Chimerism or Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia After Allogeneic Stem Cell Transplantation | |||||
| Status | Recruiting | |||||
| Sponsor | Ludwig-Maximilians-University of Munich | |||||
| NCT04044560 | Click to show the Detail | |||||
| Indication | Minimal Residual Disease (MRD) in Pre-B Cell Acute Lymphoblastic Leukemia Patients Following Hematopoietic Cell Transplantation | |||||
| Phase | Phase II | |||||
| Title | Blinatumomab for Minimal Residual Disease (MRD) in Pre-B Cell Acute Lymphoblastic Leukemia Patients Following Hematopoietic Cell Transplantation: A Canadian, Multicentre Trial | |||||
| Status | Not recruiting | |||||
| Sponsor | University of British Columbia | |||||
| NCT04307576 | Click to show the Detail | |||||
| Indication | Acute Lymphoblastic Leukaemia (ALL) | |||||
| Phase | Phase III | |||||
| Title | ALLTogether1-A Treatment Study Protocol of the ALLTogether Consortium for Children and Young Adults (1-45 Years of Age) With Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL) | |||||
| Status | Recruiting | |||||
| Sponsor | Mats Heyman | |||||
| NCT04329325 | Click to show the Detail | |||||
| Indication | Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Following Chemotherapy-Sparing Induction | |||||
| Phase | Phase II | |||||
| Title | Phase II Study of Blinatumomab and Concurrent Oral Tyrosine Kinase Inhibitor Therapy as Consolidation and Maintenance Therapy for Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Following Chemotherapy-Sparing Induction | |||||
| Status | Recruiting | |||||
| Sponsor | Memorial Sloan Kettering Cancer Center | |||||
| NCT04334993 | Click to show the Detail | |||||
| Indication | Acute Lymphoblastic Leukemia (ALL); High-risk Patients Prior to Allogeneic Transplantation | |||||
| Phase | Phase II | |||||
| Title | A Phase II, Multicenter, Single Arm Trial to Assess the Safety and Efficacy of a Pediatric Approach to for Young Adults With Acute Lymphoblastic Leukemia With?Blinatumomab?Therapy for High-risk Patients Prior to Allogeneic Transplantation | |||||
| Status | Not recruiting | |||||
| Sponsor | Israeli Medical Association | |||||
| NCT04448834 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory Philadelphia Negative CD19+ Acute Lymphoblastic Leukemia | |||||
| Phase | Phase II | |||||
| Title | A Phase II Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE? Antibody?Blinatumomab?(Blincyto) and Vincristine Sulfate Liposomal Injection (Marqibo) in Adult Subjects With Relapsed/Refractory Philadelphia Negative CD19+ Acute Lymphoblastic Leukemia | |||||
| Status | Not recruiting | |||||
| Sponsor | David Rizzieri, MD | |||||
| NCT04506086 | Click to show the Detail | |||||
| Indication | B-precursor Acute Lymphoblastic Leukemia | |||||
| Phase | Phase IV | |||||
| Title | A Phase IV, Multi-center Open-label Feasibility Study to Evaluate Outpatient Blinatumomab Administration in Adult Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL) in Complete Hematologic Remission | |||||
| Status | Not recruiting | |||||
| Sponsor | Amgen | |||||
| NCT04521231 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase I | |||||
| Title | A Phase Ib Open-label Study to Investigate the Safety and Pharmacokinetics of Administration of Subcutaneous?Blinatumomab?for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) | |||||
| Status | Not recruiting | |||||
| Sponsor | Amgen | |||||
| NCT04524455 | Click to show the Detail | |||||
| Indication | Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase I | |||||
| Title | A Phase Ib Open-label Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Administration of?Blinatumomab?in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Status | Recruiting | |||||
| Sponsor | Amgen | |||||
| NCT04530565 | Click to show the Detail | |||||
| Indication | BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults | |||||
| Phase | Phase III | |||||
| Title | A Phase III Randomized Trial of Steroids+Tyrosine Kinase Inhibitor Induction With Chemotherapy or?Blinatumomab?for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults | |||||
| Status | Recruiting | |||||
| Sponsor | National Cancer Institute (NCI) | |||||
| NCT04546399 | Click to show the Detail | |||||
| Indication | B-precursor Acute Lymphoblastic Leukemia (ALL) | |||||
| Phase | Phase II | |||||
| Title | A Phase II Study of Blinatumomab (NSC# 765986) in Combination With Nivolumab (NSC # 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged 1 to <31 Years Old With First Relapse | |||||
| Status | Not recruiting | |||||
| Sponsor | National Cancer Institute (NCI) | |||||
| NCT04554485 | Click to show the Detail | |||||
| Indication | Philadelphia chromosome-negative Acute Lymphoblastic Leukemia | |||||
| Phase | Phase II | |||||
| Title | Single Cycle of?Blinatumomab?Followed by High-dose Chemotherapy in the Induction Therapy for Ph-negative Acute Lymphoblastic Leukemia in Adults | |||||
| Status | Recruiting | |||||
| Sponsor | Institute of Hematology and Blood Transfusion, Czech Republic | |||||
| NCT04556084 | Click to show the Detail | |||||
| Indication | High-Risk B-Acute Lymphoblastic Leukemia | |||||
| Phase | Phase II | |||||
| Title | Blinatumomab?Bridging Therapy in High-Risk B-Acute Lymphoblastic Leukemia: A Phase II Study | |||||
| Status | Not recruiting | |||||
| Sponsor | Michael Burke | |||||
| NCT04604691 | Click to show the Detail | |||||
| Indication | Pediatric B-cell Precursor Acute Lymphoblastic Leukemia | |||||
| Phase | Phase I | |||||
| Title | Blinatumomab?for Minimal Residual Disease Before Hematopoietic Stem Cell Transplantation With Pediatric B-cell Precursor Acute Lymphoblastic Leukemia | |||||
| Status | Not recruiting | |||||
| Sponsor | Seoul National University Hospital | |||||
| NCT04785547 | Click to show the Detail | |||||
| Indication | ALL, Childhood; Minimal Residual Disease | |||||
| Phase | Phase II | |||||
| Title | ALL SCTped 2012 FORUM Add-on Study Blina Post HSCT | |||||
| Status | Terminated | |||||
| Sponsor | Prof. Christina Peters | |||||