Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Blinatumomab

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    48 result(s) found for: Blinatumomab. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2014-002476-92 Sponsor Protocol Number: 20120215 Start Date*: 2015-06-29
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Open-label, Controlled Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidatio...
    Medical condition: Patients with Philadelphia chromosome negative (Ph-) high-risk (HR) first relapse B-precursor ALL (as defined by I-BFM SG/IntReALL criteria)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    21.0 100000004864 10063625 Acute lymphoblastic leukemia recurrent LLT
    21.1 100000004864 10066109 Precursor B-lymphoblastic leukemia acute LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) BE (Completed) IT (Completed) SE (Completed) PT (Completed) DK (Completed) AT (Completed) GB (GB - no longer in EU/EEA) PL (Completed) ES (Ongoing) FR (Completed) NL (Completed) Outside EU/EEA GR (Completed) NO (Completed) HU (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2016-004674-17 Sponsor Protocol Number: NL59901.078.17 Start Date*: 2017-10-17
    Sponsor Name:Princess Máxima Center for Pediatric Oncology
    Full Title: A pilot study to test the feasibility, safety and efficacy of the addition of the BiTE antibody Blinatumomab to the Interfant-06 backbone in infants with MLL-rearranged acute lymphoblastic leukemia...
    Medical condition: Acute Lymphoblastic Leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) AT (Completed) BE (Completed) DK (Completed) DE (Completed) CZ (Completed) FR (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-000536-10 Sponsor Protocol Number: 00103311 Start Date*: 2013-11-13
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 3, 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 Acu...
    Medical condition: Adult patients with relapsed and/or refractory B-precursor Acute lymphoblastic leukaemia
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10000845 Acute lymphoblastic leukemia LLT
    14.1 100000004864 10063625 Acute lymphoblastic leukemia recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) CZ (Completed) DE (Completed) BE (Completed) IE (Completed) AT (Completed) GB (Completed) ES (Completed) FR (Completed) GR (Completed) PL (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2015-000733-76 Sponsor Protocol Number: GMALL-MOLACT1-BLINA Start Date*: 2016-07-28
    Sponsor Name:Goethe-Universität Frankfurt, Universitätsklinikum, Med. Klinik II
    Full 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...
    Medical condition: Patients with minimal residual disease (MRD) positive B-precursor ALL with and without prior SCT documented after an interval of at least 8 days from last systemic chemo-therapy • at a level of ≥10...
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10066104 Precursor B-lymphoblastic leukaemia acute LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-004780-52 Sponsor Protocol Number: 20180257 Start Date*: 2020-06-05
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of adults with Relapsed or Refractory B cell ...
    Medical condition: Adults with relapsed or refractory B-precursor ALL (R/R B-ALL)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000844 Acute lymphoblastic leukaemia LLT
    21.0 100000004864 10063621 Acute lymphoblastic leukaemia recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Completed) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-003778-15 Sponsor Protocol Number: 20130265 Start Date*: 2017-11-08
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 1b/2 Study of Blinatumomab in Japanese Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (Horai Study)
    Medical condition: relapsed/refractory B-precursor Acute Lymphoblastic Leukemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    20.0 100000004864 10063625 Acute lymphoblastic leukemia recurrent LLT
    20.0 100000004864 10066109 Precursor B-lymphoblastic leukemia acute LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-002190-35 Sponsor Protocol Number: 20150288 Start Date*: 2017-01-11
    Sponsor Name:Amgen Inc
    Full Title: A Phase 2 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)
    Medical condition: High-risk Diffuse Large B-Cell Lymphoma (DLBCL)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10012818 Diffuse large B-cell lymphoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) FR (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-018314-75 Sponsor Protocol Number: MT103-203 Start Date*: 2010-08-05
    Sponsor Name:Amgen Research (Munich) GmbH
    Full 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...
    Medical condition: minimal residual disease (MRD) of B-precursor ALL
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) GB (Completed) AT (Completed) ES (Completed) CZ (Completed) FR (Completed) PL (Completed) IT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2013-000706-36 Sponsor Protocol Number: 20120216 Start Date*: 2013-12-10
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 2 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 ...
    Medical condition: Adult patients with relapsed and/or refractory Philadelphia Chromosome- positive B-precursor ALL
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    16.0 100000004864 10063625 Acute lymphoblastic leukemia recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-004498-29 Sponsor Protocol Number: 20190360 Start Date*: 2022-01-13
    Sponsor Name:Amgen Inc.
    Full Title: Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor...
    Medical condition: Newly Diagnosed Philadelphia (Ph)-negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000844 Acute lymphoblastic leukaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PT (Trial now transitioned) SE (Trial now transitioned) AT (Trial now transitioned) FI (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) DK (Trial now transitioned) IT (Trial now transitioned) BE (Trial now transitioned) HU (Trial now transitioned) BG (Trial now transitioned) NL (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-002257-61 Sponsor Protocol Number: MT103-211 Start Date*: 2011-11-15
    Sponsor Name:Amgen Research (Munich) GmbH
    Full 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)
    Medical condition: Adult patients with relapsed / refractory B-precursor ALL.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-001700-21 Sponsor Protocol Number: 20130320 Start Date*: 2015-02-19
    Sponsor Name:Amgen Inc.
    Full 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...
    Medical condition: Pediatric and Adolescent Subjects with Relapsed and/or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    20.0 100000004864 10063625 Acute lymphoblastic leukemia recurrent LLT
    20.0 100000004864 10066109 Precursor B-lymphoblastic leukemia acute LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) IT (Completed) AT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2010-024264-18 Sponsor Protocol Number: MT103-205 Start Date*: 2011-11-23
    Sponsor Name:Amgen Research (Munich) GmbH
    Full 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 Pati...
    Medical condition: Pediatric and adolescent patients with B-precursor ALL in second or later bone marrow relapse, in any marrow relapse after allogeneic HSCT, or refractory to other treatments.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) NL (Completed) IT (Completed) GB (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004877-42 Sponsor Protocol Number: PETHEMA-BLIN-01 Start Date*: 2018-04-25
    Sponsor Name:FUNDACIÓN PETHEMA
    Full 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 ...
    Medical condition: Acute lymphoblastic leukaemia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004864 10000844 Acute lymphoblastic leukaemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-005781-38 Sponsor Protocol Number: MT103-208 Start Date*: 2012-06-05
    Sponsor Name:Amgen Research (Munich) GmbH
    Full Title: An Open Label, Multicenter, Exploratory Phase 2 Study to Evaluate the Efficacy and Safety of the Bispecific T-Cell Engager (BiTE) Blinatumomab in Patients with Relapsed/Refractory Diffuse Large B-C...
    Medical condition: Adult Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10012821 Diffuse large B-cell lymphoma recurrent PT
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10012822 Diffuse large B-cell lymphoma refractory PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-003483-32 Sponsor Protocol Number: FILO Start Date*: 2019-04-25
    Sponsor Name:FILO
    Full Title: BLINAtumomab after R-CHOP debulking therapy for patients with Richter Transformation.
    Medical condition: Richter transformation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-000766-30 Sponsor Protocol Number: HO146 Start Date*: 2018-03-09
    Sponsor Name:HOVON Foundation
    Full Title: Blinatumomab added to prephase and consolidation therapy in precursor B-acute lymphoblastic leukemia in adults. A phase II trial.
    Medical condition: Precursor B-acute lymphoblastic leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-003255-30 Sponsor Protocol Number: 20150291 Start Date*: 2017-10-04
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 2 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 Trans...
    Medical condition: High-risk Diffuse Large B-cell Lymphoma (DLBCL)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10012818 Diffuse large B-cell lymphoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-015989-62 Sponsor Protocol Number: MT103-206 Start Date*: 2010-08-05
    Sponsor Name:Amgen Research (Munich) GmbH
    Full 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 Ac...
    Medical condition: Patients with Relapsed/Refractory B-Precursor acute lymphoblastic leukemia (ALL)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2022-000760-21 Sponsor Protocol Number: GMALL-EVOLVE Start Date*: 2023-03-28
    Sponsor Name:Goethe-University
    Full Title: A multicentre, randomized trial in adults with de novo Philadelphia-Chromosome positive acute lymphoblastic leukemia to assess the efficacy of ponatinib versus imatinib in combination with low-inte...
    Medical condition: De novo Philadelphia-Chromosome positive acute lymphoblastic leukemia (Ph+ALL)
    Disease: Version SOC Term Classification Code Term Level
    24.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10080018 Philadelphia positive acute lymphocytic leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  Next»
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue May 13 12:37:14 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA