Trial Search Results

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

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Gilead Sciences

Stanford Investigator(s):

Intervention(s):

  • Drug: Magrolimab
  • Drug: Azacitidine

Phase:

Phase 1

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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Amishi Jobanputra
650-723-8594
Recruiting