Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL
NCT ID: NCT04524455
Last Updated: 2024-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2020-10-02
2023-01-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Blinatumomab and AMG 404
Blinatumomab
Blinatumomab will be administered as a continuous intravenous infusion (cIV).
AMG 404
AMG 404 will be administered as an intravenous infusion (IV).
Dexamethasone Premedication
Dexamethasone will be administered orally or intravenously prior to blinatumomab treatment, as needed.
Interventions
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Blinatumomab
Blinatumomab will be administered as a continuous intravenous infusion (cIV).
AMG 404
AMG 404 will be administered as an intravenous infusion (IV).
Dexamethasone Premedication
Dexamethasone will be administered orally or intravenously prior to blinatumomab treatment, as needed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Greater than or equal to 5% blasts in the bone marrow.
* Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2.
* Negative pregnancy test in women of childbearing potential.
Exclusion Criteria
* Known hypersensitivity to blinatumomab or AMG 404 or to any component of the product formulation.
18 Years
99 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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City of Hope National Medical Center
Duarte, California, United States
University of Chicago
Chicago, Illinois, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Ordensklinikum Linz Elisabethinen
Linz, , Austria
Hôpital Saint Louis
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt am Main, , Germany
Universitätsklinikum Schleswig-Holstein
Kiel, , Germany
Universitaetsklinikum Regensburg
Regensburg, , Germany
Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi
Bologna, , Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, , Italy
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain
University College London
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20190177
Identifier Type: -
Identifier Source: org_study_id
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