A Phase II Study of Entospletinib in NPM1-Mutant Acute Myeloid Leukemia in Patients Over Age 60

Full Title

BAML-16-001-S6: A Phase 2 Study of Entospletinib in NPM1 mutant/FLT3 ITD Wild Type AML Patients Age > 60 years (WIRB)

Purpose

The standard chemotherapy for acute myeloid leukemia (AML) can be difficult for some patients to tolerate, including many older patients. In this study, researchers are evaluating the safety and effectiveness of the investigational drug entospletinib, alone and in combination with chemotherapy, in patients age 60 and older with newly diagnosed AML. Entospletinib inhibits an enzyme called Syk that is overproduced by leukemia cells.

One group of patients will receive entospletinib before chemotherapy and as maintenance therapy after chemotherapy. Patients who cannot tolerate the side effects of chemotherapy will receive entospletinib alone. If their AML does not go into remission, they will then receive the drug azacitidine, which is already used to treat leukemia. Entospletinib is taken orally (by mouth), while azacitidine is given by injection. The chemotherapy drugs used in this study are given intravenously (by vein).

Eligibility

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

  • Patients must have newly diagnosed, previously untreated AML that contains the NPM1 mutation but not the FLT3 ITD mutation.
  • Patients may not have previously received treatment for AML.
  • This study is for patients age 60 and older who are able to walk and do routine activities for more than half of their normal waking hours.
  • Patients in the chemotherapy group must be under age 75. They must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.

For more information and to inquire about eligibility for this study, please contact Dr. Eytan Stein at 212-639-3314.

Protocol

17-554

Phase

II

Investigator

Co-Investigators