A Phase IB/II Study of Entospletinib Alone and with Chemotherapy in Older Patients Newly Diagnosed with Acute Myeloid Leukemia

Full Title

BAML-16-001-S4: A Phase 1b/2 Study of Entospletinib (ENTO) in Patients with Acute Myeloid Leukemia (AML) >/= Age 60 with MLL Gene Rearrangements and/or MLL-Partial Tandem Duplications (MLL-PTD)(WIRB)

Purpose

Acute myeloid leukemia (AML) that is considered “mixed lineage leukemia” (MLL) 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 MLL genetic alterations. Entospletinib inhibits an enzyme called Syk that is overproduced by leukemia cells.

Patients will initially receive entospletinib alone. If there is evidence that the drug is working against their leukemia, they will continue to receive this medication for up to five years. If their AML does not respond to entospletinib after one cycle, they will also receive the drug azacitidine, which is already used to treat leukemia. Entospletinib is taken orally (by mouth), while azacitidine is given by injection.

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 is considered MLL.
  • 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

17-406

Phase

I/II

Investigator

Co-Investigators