Acute Myeloid Leukemia Clinical Trial
Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Participants With Hematological Malignancies
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
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.
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There are 27 Locations for this study
Duarte California, 91010, United States
La Jolla California, 92093, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Sacramento California, 95817, United States
Stanford California, 94305, United States
Aurora Colorado, 80045, United States
Miami Florida, 33136, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60637, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Kansas City Missouri, 64132, United States
Bronx New York, 10467, United States
Buffalo New York, 14263, United States
New York New York, 10021, United States
New York New York, 10029, United States
New York New York, 10032, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27705, United States
Columbus Ohio, 43210, United States
Oklahoma City Oklahoma, 73104, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Milwaukee Wisconsin, 53226, United States
Oxford , OX3 7, United Kingdom
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