A Phase III Study of High-Dose Chemotherapy with and without CPI-613 in Older Patients with Recurrent or Persistent Acute Myeloid Leukemia

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Full Title

Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of CPI-613TM (devimistat) in Combination with High Dose Cytarabine and Mitoxantrone (CHAM) Compared to High Dose Cytarabine and Mitoxantrone (HAM) therapy and control sub-groups: combination of Mitoxantrone, Etoposide and Cytarabine (MEC) and combination of Fludarabine, Cytarabine, and Filgrastim (FLAG) in Older Patients (>=50 years) with Relapsed/Refractory Acute Myeloid Leukemia (AML) (WIRB)

Purpose

In this study, researchers want to see if adding the investigational drug CPI-613 (devimistat) to treatment with high-dose cytarabine and mitoxantrone is more effective than high-dose cytarabine and mitoxantrone alone in people age 60 and over with acute myeloid leukemia (AML) that has come back or continued to grow despite standard therapies.

CPI-613 works by blocking the creation of the energy that cancer cells need to survive, grow, and make more cancer cells. When the energy production they need is blocked, the cancer cells can no longer survive. Patients in this study will be randomly assigned to receive high-dose cytarabine and mitoxantrone alone or in combination with CPI-613. All of these medications 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 AML that has come back or continued to grow despite standard treatments.
  • At least 2 weeks must pass between the completion of prior therapies and receipt of the study treatment.
  • 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 about this study and to inquire about eligibility, please contact Dr. Martin Tallman at 646-608-3754.

Protocol

20-188

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators