Flotetuzumab Expanded Access Program

MacroGenics

Status

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

Treatments: Biological: flotetuzumab

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT04678466

MGD006-EA

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

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