Back to resultsFlotetuzumab Expanded Access Program
Primary Purpose
Acute Myeloid Leukemia, AML, AML, Adult Recurrent
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
flotetuzumab
Sponsored by
About this trial
This is an expanded access trial for Acute Myeloid Leukemia
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04678466
Brief Title
Flotetuzumab Expanded Access Program
Official Title
An Expanded Access Program Providing Flotetuzumab in the Treatment of Acute Myeloid Leukemia Patients in Single, Individually-approved Patients
Study Type
Expanded Access
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MacroGenics
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, AML, AML, Adult Recurrent
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
flotetuzumab
Other Intervention Name(s)
MGD006
Intervention Description
CD123 x CD3 bispecific DART® antibody
10. Eligibility
Sex
All
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Ward, MD
Organizational Affiliation
MacroGenics
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Flotetuzumab Expanded Access Program
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