We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

US Expanded Access Program for Magrolimab in Patients With Relapsed or Refractory Higher-risk Myelodysplastic Syndrome or Relapsed or Refractory Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05627466
Expanded Access Status : Available
First Posted : November 25, 2022
Last Update Posted : May 9, 2023
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information
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 higher-risk myelodysplastic syndrome (MDS) or relapsed or refractory acute myeloid leukemia (AML).

Condition or disease Intervention/treatment
Relapsed/Refractory Higher-Risk Myelodysplastic Syndrome Relapsed/Refractory Acute Myeloid Leukemia Drug: Magrolimab

Study Design
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access Program for Magrolimab

Resource links provided by the National Library of Medicine


Interventions
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Drug: Magrolimab
    Administered intravenously
    Other Name: GS-4721
Eligibility Criteria
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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 (SIRPα)-targeting agents.

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05627466


Contacts
Layout table for location contacts
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com
Contact: Bionical Emas patient.access@bionical-emas.com

Sponsors and Collaborators
Gilead Sciences
Investigators
Layout table for investigator information
Study Director: Gilead Study Director Gilead Sciences
More Information
Go to 
Top of Page Study Description Study Design Interventions Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT05627466    
Other Study ID Numbers: GS-US-546-6531
First Posted: November 25, 2022    Key Record Dates
Last Update Posted: May 9, 2023
Last Verified: May 2023
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
 Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Magrolimab
Antineoplastic Agents, Immunological
Antineoplastic Agents