Status:
COMPLETED
Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL
Lead Sponsor:
Amgen
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
The primary objective of this phase 1b study is to evaluate the safety and tolerability of blinatumomab and AMG 404 in combination in adults with R/R B-ALL and to estimate the maximum tolerated dose (...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age ≥ 18 years at enrollment.
- 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
- Cancer chemotherapy (radiotherapy, chemotherapy, antibody therapy, molecular targeted therapy) within 14 days prior to study Day 1.
- Known hypersensitivity to blinatumomab or AMG 404 or to any component of the product formulation.
Exclusion
Key Trial Info
Start Date :
October 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04524455
Start Date
October 2 2020
End Date
January 24 2023
Last Update
April 8 2024
Active Locations (19)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
University of Chicago
Chicago, Illinois, United States, 60637
3
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
4
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195