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

Individual Patients
Acute Myeloid Leukemia
AML, Adult Recurrent

Biological: flotetuzumab
CD123 x CD3 bispecific DART® antibody
Other Name: MGD006

Eligibility Criteria

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

Eligibility Gender

Anabela Goncalves

Ashley Ward, MD
Study Director

NCT Number
MeSH Terms
Leukemia, Myeloid
Leukemia, Myeloid, Acute