- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04678466
Flotetuzumab Expanded Access Program
May 24, 2022 updated by: MacroGenics
An Expanded Access Program Providing Flotetuzumab in the Treatment of Acute Myeloid Leukemia Patients in Single, Individually-approved Patients
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.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
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 Type
Expanded Access
Expanded Access Type
- Individual Patients
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ashley Ward, MD, MacroGenics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
December 16, 2020
First Submitted That Met QC Criteria
December 16, 2020
First Posted (Actual)
December 22, 2020
Study Record Updates
Last Update Posted (Actual)
May 31, 2022
Last Update Submitted That Met QC Criteria
May 24, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MGD006-EA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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