Study Details

PROTOCOL 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

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

Medical Condition

Hematological Malignancies

Gender

N/A

Date

September 2017 - September 2023

Study Type

Interventional

Study Phase

Phase 1

Product

Magrolimab, Azacitidine

Eligibility Information

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

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.

Locations

Locations (27)

City of Hope National Medical Center

Duarte, California, United States, 91010

University of California San Diego (UCSD)

La Jolla, California, United States, 92093

UCLA Clinical and Translational Research Center (CTRC)

Los Angeles, California, United States, 90095

Chao Family Comprehensive Cancer Center - UC Irvine Medical Center

Orange, California, United States, 92868

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States, 95817

Stanford University Medical Center

Stanford, California, United States, 94305

University of Colorado Cancer Center

Aurora, Colorado, United States, 80045

University Of Miami - Miller School Of Medicine, Sylvester Comprehensive Cancer Center

Miami, Florida, United States, 33136

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States, 33612

The University of Chicago

Chicago, Illinois, United States, 60637

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Dana Farber Cancer Institute/ Boston Children's Hospital

Boston, Massachusetts, United States, 02215

Mid America Division, Inc.

Kansas City, Missouri, United States, 64132

Montefiore Medical Center

Bronx, New York, United States, 10467

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Weill Cornell Medical College - New York-Presbyterian Hospital

New York, New York, United States, 10021

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Herbert Irving Comprehensive Cancer Center-Columbia University Medical Center

New York, New York, United States, 10032

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Duke University Medical Center

Durham, North Carolina, United States, 27705

Ohio State University Medical Center

Columbus, Ohio, United States, 43210

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States, 73104

Tennesssee Oncology - Centennial Clinic Location

Nashville, Tennessee, United States, 37203

Texas Oncology - Baylor Charles A. Simmons Cancer Center

Dallas, Texas, United States, 75246

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Medical College of WI Froedtert Hospital

Milwaukee, Wisconsin, United States, 53226

Oxford Centre for Respiratory Medicine Churchill Hospital, Oxford University Hospitals NHS Trust

Oxford, United Kingdom, OX3 7LE

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

OVERVIEW