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Clinical Trial Details — Status: No longer available

Administrative data

NCT number NCT05627466
Other study ID # GS-US-546-6531
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information

Verified date February 2024
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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).


Recruitment information / eligibility

Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 (SIRPa)-targeting agents. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Magrolimab
Administered intravenously

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences
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