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Clinical Trials/NCT04678466
NCT04678466No Longer AvailableNot Applicable

An Expanded Access Program Providing Flotetuzumab in the Treatment of Acute Myeloid Leukemia Patients in Single, Individually-approved Patients

MacroGenics0 sitesStarted: December 22, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
No Longer Available
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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 MacroGenics to supply flotetuzumab for single patient use.

Study Design

Study Type
Expanded Access

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Weight of at least 17 kilograms
  • •CD123-positive hematologic malignancy
  • •Adequate organ reserve
  • •Provider and site are trained on study protocol using flotetuzumab

Exclusion Criteria

  • •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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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