Acute Myeloid Leukemia Clinical Trial

Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Participants With Hematological Malignancies

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 (MDS) population, and of magrolimab in combination with azacitidine in previously untreated participants with AML or MDS and participants with R/R AML and MDS
To evaluate the efficacy of magrolimab monotherapy in R/R AML/MDS, and of magrolimab in combination with azacitidine in previously untreated participants with AML/MDS, or R/R AML/MDS as measured by complete remission (CR) rate for participants with AML and higher-risk MDS, and duration of complete response for participants with AML and higher-risk MDS, and duration of CR for participants with AML and higher-risk MDS
To evaluate the safety, tolerability, and efficacy of magrolimab monotherapy or combination with azacitidine in low-risk MDS participants as measured by red blood cell (RBC) transfusion independence rate

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Meets the criteria below for the appropriate cohort:

Relapsed/Refractory Cohorts: Pathologically confirmed relapsed or refractory (primary refractory and/or relapsed refractory) AML or confirmed intermediate, high, or very high risk 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 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 Criteria:

Prior treatment with 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.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

258

Study ID:

NCT03248479

Recruitment Status:

Terminated

Sponsor:

Gilead Sciences

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There are 27 Locations for this study

See Locations Near You

City of Hope National Medical Center
Duarte California, 91010, United States
University of California San Diego (UCSD)
La Jolla California, 92093, United States
UCLA Clinical and Translational Research Center (CTRC)
Los Angeles California, 90095, United States
Chao Family Comprehensive Cancer Center - UC Irvine Medical Center
Orange California, 92868, United States
University of California Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
Stanford University Medical Center
Stanford California, 94305, United States
University of Colorado Cancer Center
Aurora Colorado, 80045, United States
University Of Miami - Miller School Of Medicine, Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa Florida, 33612, United States
The University of Chicago
Chicago Illinois, 60637, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute/ Boston Children's Hospital
Boston Massachusetts, 02215, United States
Mid America Division, Inc.
Kansas City Missouri, 64132, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Weill Cornell Medical College - New York-Presbyterian Hospital
New York New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Herbert Irving Comprehensive Cancer Center-Columbia University Medical Center
New York New York, 10032, United States
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27599, United States
Duke University Medical Center
Durham North Carolina, 27705, United States
Ohio State University Medical Center
Columbus Ohio, 43210, United States
Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Tennesssee Oncology - Centennial Clinic Location
Nashville Tennessee, 37203, United States
Texas Oncology - Baylor Charles A. Simmons Cancer Center
Dallas Texas, 75246, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Medical College of WI Froedtert Hospital
Milwaukee Wisconsin, 53226, United States
Oxford Centre for Respiratory Medicine Churchill Hospital, Oxford University Hospitals NHS Trust
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

258

Study ID:

NCT03248479

Recruitment Status:

Terminated

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

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