US Expanded Access Program for Magrolimab in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Gilead Sciences

Status

Conditions: Relapsed/Refractory Acute Myeloid Leukemia

Treatments: Drug: Magrolimab

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT05627466

GS-US-546-6531

Details and patient eligibility

About

The goal of this expanded access program is to provide rapid access to magrolimab free-of-cost material, to treat patients in the United States suffering from relapsed or refractory acute myeloid leukemia (AML).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Individuals with confirmation of acute myeloid leukemia (AML) according to WHO 2016 classification who are refractory or relapsed, ineligible for all known drugs with proven efficacy, and ineligible for existing clinical studies; and the treating physician has assessed that the potential benefits of magrolimab outweigh the risks.
• Eastern Cooperative Oncology Group performance status score of 0 to 3.
• Treating physician plans to administer magrolimab in combination with azacitadine/venetoclax or magrolimab in combination with azacitadine alone, following the indication-specific combinations described in the protocol.

Key Exclusion Criteria:

• Known hypersensitivity to magrolimab, azacitidine, venetoclax, their metabolites, or formulation excipients, if applicable to planned treatment regimen.
• Prior treatment with cluster of differentiation (CD)47 or signal regulatory protein alpha (SIRPα)-targeting agents.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.