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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)

Active: No
Cancer Type: Leukemia NCT ID: NCT02997202
Trial Phases: Phase III Protocol IDs: 2215-CL-0304 (primary)
NCI-2017-01112
2016-001061-83
BMT CTN 1506
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
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 in Georgia

Georgia Cancer Center at Augusta University
1411 Laney Walker Boulevard
Augusta, GA 30912
www.augusta.edu/cancer/



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



Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.