A Phase IB/II Study of KRT-232 and Cytarabine or Decitabine in People with Acute Myeloid Leukemia

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Full Title

An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined with Low-Dose Cytarabine (LDAC) or Decitabine in Patients with Acute Myeloid Leukemia (AML)

Purpose

The purpose of this study is to find the highest dose of the investigational drug KRT-232 that can be given safely with cytarabine and with decitabine in patients with acute myeloid leukemia (AML). Researchers want to see if KRT-232 can reduce the growth of unhealthy cells or cancer cells and help the bone marrow make healthy blood-forming cells.

Patients in this study will receive KRT-232 with either cytarabine or decitabine. KRT-232 is taken orally (by mouth), cytarabine is given by injection, and 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 AML that has come back or continued to grow despite treatment, or new AML that developed as a result of a myeloproliferative neoplasm.
  • At least 2 weeks must pass between the completion of prior chemotherapy or immunotherapy and entry into the study.
  • 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 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Raajit Rampal at 212-639-2194.

Protocol

20-071

Phase

I/II

Investigator

Co-Investigators