A Phase III Study of Gilteritinib as Maintenance Therapy after Stem Cell Transplantation for Patients with FLT3/ITD-Mutated Acute Myeloid Leukemia

Full Title

BMT CTN 1506/2215-CL-0304: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with FLT3/ITD AML

Purpose

Some patients with acute myeloid leukemia (AML) have a specific genetic mutation (abnormality) in their leukemia cells called the FLT3/ITD mutation. Patients with this mutation are more likely to experience a relapse of their disease after standard chemotherapy. Having an allogeneic stem cell transplant (receiving healthy stem cells from a matched donor) is recommended after chemotherapy in these patients to reduce the risk of the leukemia coming back.

In this study, researchers want to see if taking the investigational drug gilteritinib lowers the risk of AML recurrence after an allogeneic stem cell transplant. Gilteritinib (also called ASP2215) may help kill leukemia cells by blocking the pathways that FLT3-positive cells use to grow and divide. Patients will be randomly assigned to receive gilteritinib or a placebo (inactive pill). Gilteritinib is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have FLT3-ITD-mutated AML in first remission and be eligible for stem cell transplantation.
  • Patients must have a source of donated stem cells (related or unrelated donor or umbilical cord blood).
  • Patients may not have received more than two cycles of induction chemotherapy to achieve first remission.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Esperanza Papadopoulos at 212-639-8276.

Protocol

17-563

Phase

III

Co-Investigators