Flotetuzumab Expanded Access Program

N/ANo Longer AvailableNCT04678466

MacroGenics

Overview

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.

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 Type

EXPANDED_ACCESS

Conditions

Acute Myeloid Leukemia AML AML, Adult Recurrent

Interventions

flotetuzumabBIOLOGICAL

CD123 x CD3 bispecific DART® antibody

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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