Bone marrow aspirate showing acute myeloid leukemia. Credit: VashiDonsk at English Wikipedia.

Rafael Pharmaceuticals has commenced the Phase III ARMADA 2000 trial to investigate the efficacy and safety of CPI-613 (devimistat) in comparison with high dose cytarabine and mitoxantrone (CHAM) for the treatment of older patients with relapsed or refractory acute myeloid leukemia (AML).

The trial intends to enrol a total of 500 patients at around 87 sites in 12 countries worldwide.

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It will include patients aged 60 or over with relapsed or refractory AML and an Eastern Cooperative Oncology Group (ECOG) performance status of zero to two.

The trial’s primary efficacy endpoint is complete remission (CR), while secondary endpoints comprise overall survival (OS), complete remission with partial hematologic recovery (CRh) and safety.

“We believe that CPI-613 has the potential to change the course of treatment in elderly patients with AML.”

Interim analysis of the trial is scheduled to be completed by the first quarter of 2020.

Rafael Pharmaceuticals president and CEO Sanjeev Luther said: “Our motto, ‘To Save A Life Is To Save A Universe,’ reflects our commitment to develop potential treatments for patients with significant unmet clinical needs.

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“Initiation of our ARMADA 2000 trial is a significant milestone in that direction. We believe that CPI-613 has the potential to change the course of treatment in elderly patients with AML.

Rafael previously conducted a Phase I dose escalation study called CCCWFU 22112 to analyse the safety, tolerability and efficacy of CHAM in patients with relapsed or refractory AML.

The trial included 67 patients and evaluated 62 of them for response.

Findings of the trial showed a 50% overall response rate with median survival of 6.7 months.