A Phase II Study of Midostaurin to Prevent Relapse After Allogeneic Stem Cell Transplantation in Patients with FLT3-ITD Mutated Acute Myeloid Leukemia

Protocol
13-242
Full Title
A Phase II, Randomized, Comparative Trial of Standard of Care, With or Without Midostaurin to Prevent Relapse Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients with FLT3-ITD Mutated Acute Myeloid Leukemia
Phase
II
Purpose

The donation of stem cells from a matched donor (allogeneic stem cell transplant) is a way to treat acute myeloid leukemia (AML). However, patients are at risk for a return (relapse) of their cancer. Some patients with AML have cancer that is driven by a mutated form of the FLT3-ITD protein.

In this study, researchers want to see if giving the investigational drug midostaurin (PKC412) to patients with FLT3-ITD mutated AML after an allogeneic stem cell transplant reduces the risk of relapse. Midostaurin inhibits the growth of AML cells by blocking the activity of the FLT3-ITD protein, which the cancer cells need to grow.

Midostaurin is taken orally (by mouth). Patients in this study will be randomly assigned to have standard care (allogeneic stem cell transplantation alone) or to receive midostaurin after their transplant.

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 and have achieved a first complete remission following allogeneic stem cell transplantation.
  • Patients must be able to be walk and do routine activities for more than half of their normal waking hours.
  • This study is open to patients aged 18 to 60.

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

Disease(s)
Leukemia: Acute Myelocytic Leukemia
Leukemia: Acute Myelogenous Leukemia
Locations