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

Primary Purpose

Relapsed/Refractory Acute Myeloid Leukemia

Status
Temporarily not available
Phase
Locations
Study Type
Expanded Access
Intervention
Magrolimab
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Relapsed/Refractory Acute Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 16, 2022
    Last Updated
    September 7, 2023
    Sponsor
    Gilead Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05627466
    Brief Title
    US Expanded Access Program for Magrolimab in Patients With Relapsed or Refractory Acute Myeloid Leukemia
    Official Title
    Expanded Access Program for Magrolimab
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Temporarily not available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Gilead Sciences

    4. Oversight

    5. Study Description

    Brief Summary
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Relapsed/Refractory Acute Myeloid Leukemia

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Magrolimab
    Other Intervention Name(s)
    GS-4721
    Intervention Description
    Administered intravenously

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gilead Study Director
    Organizational Affiliation
    Gilead Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.yourpatientaccess.com
    Description
    Click on this link to request access through the Bionical Emas Patient Access Portal
    URL
    https://www.gileadclinicaltrials.com/study/?id=GS-US-546-6531
    Description
    Gilead Clinical Trials Website

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

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