Expanded Access Program for Magrolimab

Sponsor
Gilead Sciences (Industry)
Overall Status
Available
CT.gov ID
NCT05627466
Collaborator
(none)

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
  • Biological: Magrolimab

Study Design

Study Type:
Expanded Access
Official Title:
Expanded Access Program for Magrolimab

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Key Inclusion Criteria:
    • 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.

    • 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 (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:

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT05627466
    Other Study ID Numbers:
    • GS-US-546-6531
    First Posted:
    Nov 25, 2022
    Last Update Posted:
    Jan 20, 2023
    Last Verified:
    Jan 1, 2023
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 20, 2023