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

Not Recruiting

Trial ID: NCT03248479

Purpose

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

Official Title

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

Stanford Investigator(s)

Gabriel Mannis
Gabriel Mannis

Associate Professor of Medicine (Hematology)

Eligibility


Key Inclusion Criteria:

   - Meets the criteria below for the appropriate cohort:

      1. 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

      2. 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.

      3. 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

      4. 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.

Intervention(s):

drug: Azacitidine

drug: Magrolimab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ji Hyun Choi
650-723-8594

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