Flotetuzumab Expanded Access Program

• Conditions: Acute Myeloid Leukemia; AML; AML, Adult Recurrent

• Registration Number: NCT04678466
• Lead Sponsor: MacroGenics

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 Timeline

• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-22
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified