Status:
TERMINATED
Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Participants With Hematological Malignancies
Lead Sponsor:
Gilead Sciences
Conditions:
Hematological Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objectives of this study are: * To confirm the safety and tolerability of magrolimab monotherapy in a relapsed/refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome (...
Eligibility Criteria
Inclusion
- Key
- Meets the criteria below for the appropriate cohort:
- Relapsed/Refractory Cohorts: Pathologically confirmed relapsed or refractory (primary refractory and/or relapsed refractory) acute myeloid leukemia (AML) or confirmed intermediate, high, or very high risk myelodysplastic syndromes (MDS) that is relapsed, refractory or intolerant to conventional therapy.
- Treatment-naive/Unfit Cohorts: Previously untreated individuals with histological confirmation of AML who are ineligible for treatment with a standard cytarabine and anthracycline induction regimen; or previously untreated individuals with intermediate, high, or very high risk MDS. Prior and concurrent therapy with hydroxyurea, oral etoposide, erythroid and/or myeloid growth factors is allowed.
- Rollover Cohort: Individuals on active magrolimab therapy on the Phase 1 AML (SCI-CD47-002; NCT02678338) trial who are deriving clinical benefit by Investigator assessment.
- RBC transfusion dependent low risk MDS cohort: Transfusion-dependent MDS individuals who are very low or low risk by Revised International Prognostic Scoring System (IPSS-R) with previous treatment with an erythroid stimulating agent or lenalidomide.
- White blood cell (WBC) count ≤ 20 x 10\^3/mcL
- Adequate performance status and hematological, liver, and kidney function.
- Key
Exclusion
- Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPα) targeting agents (with exception of magrolimab for individuals in the Rollover cohort).
- Treatment-naive/Unfit Cohorts Only: Any prior anti-leukemic therapy (excluding hydroxyurea or oral etoposide), prior treatment with hypomethylating agents and/or low dose cytarabine.
- Acute promyelocytic leukemia.
- Known inherited or acquired bleeding disorders.
- Previous allogeneic hematopoietic stem cell transplant within 6 months prior to enrollment, active graft versus host disease (GVHD), or requiring transplant-related immunosuppression.
- Clinical suspicion of active central nervous system (CNS) involvement by leukemia.
- Known active or chronic hepatitis B or C infection or HIV.
- Pregnancy or active breastfeeding.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
September 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2023
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT03248479
Start Date
September 8 2017
End Date
September 5 2023
Last Update
January 17 2025
Active Locations (27)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
University of California San Diego (UCSD)
La Jolla, California, United States, 92093
3
UCLA Clinical and Translational Research Center (CTRC)
Los Angeles, California, United States, 90095
4
Chao Family Comprehensive Cancer Center - UC Irvine Medical Center
Orange, California, United States, 92868