Expanded Access Program for Magrolimab
Study Details
Study Description
Brief Summary
The primary objective of this study is to provide rapid access to magrolimab free-of-cost material, to treat patients in the United States suffering from relapsed or refractory higher-risk myelodysplastic syndrome (MDS) or relapsed or refractory acute myeloid leukemia (AML).
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Individuals with relapsed or refractory myelodysplastic syndrome (MDS) defined according to World Health Organization (WHO) 2016 classification with an Revised International Prognostic Scoring System (IPSS-R) prognostic risk category of intermediate, high, or very high risk 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.
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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.
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Eastern Cooperative Oncology Group performance status score of 0 to 3.
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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:
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Known hypersensitivity to magrolimab, azacitidine, venetoclax, their metabolites, or formulation excipients, if applicable to planned treatment regimen.
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Prior treatment with cluster of differentiation (CD)47 or signal regulatory protein alpha (SIRPĪ±)-targeting agents.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Click on this link to request access through the Bionical Emas Patient Access Portal
- Gilead Clinical Trials Website
Publications
None provided.- GS-US-546-6531