Status:
NO_LONGER_AVAILABLE
Flotetuzumab Expanded Access Program
Lead Sponsor:
MacroGenics
Conditions:
Acute Myeloid Leukemia
AML
Eligibility:
All Genders
Brief Summary
The purpose of the Expanded Access program is to provide flotetuzumab to patients with acute myeloid leukemia (AML) for whom potential benefit justifies potential treatment risks.
Detailed Description
MacroGenics will consider, on a case-by-case basis, requests by treating physicians to file a single patient investigational new drug application for expanded access to flotetuzumab and for MacroGenic...
Eligibility Criteria
Inclusion
- Weight of at least 17 kilograms
- CD123-positive hematologic malignancy
- Adequate organ reserve
- Provider and site are trained on study protocol using flotetuzumab
Exclusion
- AML that meets inclusion criteria for study CP-MGD006-01 (NCT02152956)
- Primary induction failure
- Early relapse (less than 6 months after first complete remission )
- Three prior lines of therapy, including maximum of 1 prior salvage attempts
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04678466
Last Update
May 31 2022
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