STATUS Terminated

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

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

STATUS

Terminated

GILEAD STUDY ID

5F9005

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

LAST UPDATED

January 17, 2025

Clinicaltrials.gov ID

NCT03248479

EudraCT ID

2017-000678-12

STUDY DOCUMENTS

View study documents

OVERVIEW

A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Patients With Hematological Malignancies

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

Study details

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) 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.

Exclusion criteria

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.

Locations

Locations (27)

City of Hope National Medical Center

Duarte, California, United States, 91010

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

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OVERVIEW

PROTOCOL SUMMARY

Participation requirements

Study details

Eligibility information

Inclusion criteria

Exclusion criteria

Locations

Locations (27)

City of Hope National Medical Center

University of California San Diego (UCSD)

UCLA Clinical and Translational Research Center (CTRC)

Chao Family Comprehensive Cancer Center - UC Irvine Medical Center

University of California Davis Comprehensive Cancer Center

Stanford University Medical Center

University of Colorado Cancer Center

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

H. Lee Moffitt Cancer Center & Research Institute

The University of Chicago

Massachusetts General Hospital

Dana Farber Cancer Institute/ Boston Children's Hospital

Mid America Division, Inc.

Roswell Park Cancer Institute

Weill Cornell Medical College - New York-Presbyterian Hospital

Icahn School of Medicine at Mount Sinai

Herbert Irving Comprehensive Cancer Center-Columbia University Medical Center

Montefiore Medical Center

University of North Carolina at Chapel Hill

Duke University Medical Center

Ohio State University Medical Center

Stephenson Cancer Center

Tennesssee Oncology - Centennial Clinic Location

Texas Oncology - Baylor Charles A. Simmons Cancer Center

The University of Texas MD Anderson Cancer Center

Medical College of WI Froedtert Hospital

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