A Phase II Study of Entospletinib and Decitabine in Older Patients with Newly Diagnosed Acute Myeloid Leukemia

Full Title

BAML-16-001-S5: A Phase 2 Study of Entospletinib and Decitabine Targeting Mutant TP53 and or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia > Age 60 years (WIRB)

Purpose

Acute myeloid leukemia (AML) with multiple genetic abnormalities is challenging to treat successfully. The standard treatment also has side effects that may be difficult for older patients to tolerate. In this study, researchers are evaluating the safety and effectiveness of the investigational drug entospletinib in patients age 60 and older with newly diagnosed AML that has multiple genetic alterations.

Entospletinib inhibits an enzyme called Syk that is overproduced by leukemia cells. Patients will receive it alone for five days and then in combination with decitabine, a standard drug used to treat blood cancers. After this combination chemotherapy, patients will then receive entospletinib alone as maintenance therapy for up to five years. Entospletinib is taken orally (by mouth), while decitabine is 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 has a TP53 mutation and/or a “complex karyotype” (three or more genetic abnormalities).
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 60 and older.

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

Protocol

17-555

Phase

II

Investigator

Co-Investigators