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Maintenance Therapy Study for Patients with FLT3/ITD Acute Myeloid Leukemia

Clinical Trial Title: 
Trial of gilteritinib administered as maintenance therapy following allogeneic transplant for patients with FLT3/ITD acute myeloid leukemia (AML).
Clinical Trial Protocol ID: 
17042503
Clinical Trial Investigator Name: 
Sunita Nathan, MD
Clinical Trial Protocol Description: 

Leukemia is cancer of the white blood cells. In acute myeloid leukemia (AML), there are too many of a specific type of white blood cell called a myeloblast. “Acute” means that this leukemia can progress quickly if not treated, and would probably be fatal in a few months. “Myeloid” refers to the type of cells this leukemia starts from. AML is the most common type of acute leukemia in adults.

A bone marrow transplant is a procedure to replace damaged or destroyed bone marrow with healthy bone marrow stem cells. An allogeneic transplant uses cells donated from a family member, an unrelated donor or an umbilical cord blood unit. Given the aggressive nature of AML and the exceptionally poor prognosis at relapse, allogeneic bone marrow transplant is now widely recommended for these patients. 

Gilteritinib is an inhibitor of the receptor tyrosine kinases FMS-related tyrosine kinase 3 with potential anti-cancer activity. Gilteritinib binds to and inhibits both the wild-type and mutated forms of FLT3, AXL and ALK. This may result in an inhibition of FLT3, AXL, and ALK-mediated signal pathways and reduction of tumor cell growth in cancer cell types that overexpress these receptor tyrosine kinases (RTKs).

This is a multi-center phase III clinical trial which will evaluate the impact of maintenance therapy with the FLT3 inhibitor gilteritinib on the relapse-free survival of participants with FLT3/ITD AML who have successfully undergone allogeneic hematopoietic stem cell transplant. A maintenance period of 2 years has been chosen based on Center for International Blood and Marrow Transplant Research data which indicate the vast majority of AML relapses occur by this time after allogeneic hematopoietic stem cell transplant.

The study is placebo-controlled and double-blinded, the results that emerge from this study will establish whether or not FLT3 inhibition in this setting can prevent relapse, and whether or not there is an impact on graft versus host disease in these participants. Additionally, the trial may establish the utility of monitoring minimal residual disease (MRD). A validated MRD assay would represent an important advance for the field, as it would allow for the design of more efficient trials testing new drugs/agents for the treatment of FLT3/ITD AML.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Are a good candidate for hematopoietic stem cell transplant (HCT) and have an acceptable source of allogeneic donor stem cells.
  • Have a confirmed AML diagnosis that is in first complete remission.
  • Have the presence of the FLT3/ITD activating mutation in your bone marrow.
  • Are able to take oral medication.

You will be excluded from the study if any of the following criteria apply to you:

  • Have had a previous HCT.
  • Take drugs not allowed by the study.
  • Have had a heart attack within 6 months prior to registering for this study.
  • Are pregnant or breastfeeding.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Blood Disorders and Hematologic Cancers
Contact Phone: 
(312) 942-5798
Contact Name: 
Melissa Quaiver, RN