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A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)

Status
Completed
Cancer Type
Leukemia
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT02997202
Protocol IDs
2215-CL-0304 (primary)
NCI-2017-01112
2016-001061-83
BMT CTN 1506
Study Sponsor
Astellas Pharma Global Development, Inc.
NCI Full Details
http://clinicaltrials.gov/show/NCT02997202

Summary

The purpose of this study is to compare relapse-free survival between participants with
FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem
cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after
the time of engraftment for a two year period.

Objectives

Participants with FLT3/ITD AML in first morphologic complete remission (CR1) undergoing
allogeneic hematopoietic stem cell transplant (HCT) will be randomized to receive
gilteritinib or placebo 30 to 90 days after HCT for a two year period. Participants will be
stratified according to: 1) conditioning regimen intensity (myeloablative vs. reduced
intensity/non-myeloablative), 2) time from first day of hematopoietic cell infusion to
randomization (30-60 days vs. 61-90 days) and 3) presence vs absence of or unknown minimal
residual disease (MRD) from the most recent pre-registration bone marrow (BM) aspirate.

Treatment Sites


Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
Northside Hospital Central Research Department
404-303-3355
www.northside.com

Study Coordinator:
Stacey Brown
404-780-7965

Doctors:

Asad Bashey MD, PhD
H. Kent Holland MD
Lawrence E. Morris, Jr. MD
Scott R. Solomon MD
Melhem Solh MD
 
For a complete listing of all trial sites in Georgia, please visit GeorgiaCancerInfo.org
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