Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Patients With Hematological Malignancies
Age: 18 years - 66+
Healthy Subjects: No
Study Phase: Phase 1
Recruitment Status: Recruiting
Start Date: September 12, 2017
End Date: August 01, 2022
- 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-naïve/ Unfit Cohorts: Previously untreated patients with histological confirmation of AML who are ineligible for treatment with a standard cytarabine and anthracycline induction regimen; or previously untreated patients 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: Patients on active magrolimab therapy on the Phase 1 AML (SCI-CD47-002) trial who are deriving clinical benefit by Investigator assessment
4. RBC transfusion dependent low risk MDS cohort: Transfusion-dependent MDS patients 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 10E3/µL
- Adequate performance status and hematological, liver, and kidney function
- Prior treatment with CD47 or signal regulatory protein alpha (SIRPα) targeting agents (with exception of magrolimab for patients in the Rollover cohort).
- Treatment-naïve/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