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NCT04678466 Clinical Trial

Flotetuzumab Expanded Access Program

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT04678466
Other study ID # MGD006-EA
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date May 2022
Source MacroGenics
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• flotetuzumab
CD123 x CD3 bispecific DART® antibody

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
MacroGenics
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