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Flotetuzumab Expanded Access Program

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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT04678466
Enrollment
Unknown
Registered
2020-12-22
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, AML, AML, Adult Recurrent

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.

Interventions

BIOLOGICALflotetuzumab

CD123 x CD3 bispecific DART® antibody

Sponsors

MacroGenics
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026