Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML

Summary

A Phase III study to evaluate the safety and efficacy of CPI-613® (devimistat) in combination with High Dose Cytarabine and Mitoxantrone in comparison with high dose Cytarabine and Mitoxantrone and control sub-groups: combination of Mitoxantrone, Etoposide and Cytarabine (MEC) and combination of Fludarabine, Cytarabine, and Filgrastim (FLAG) in older patients with relapsed/refractory Acute Myeloid Leukemia. CPI-613® (devimistat) targets the altered energy metabolism and processes for production of ATP and essential bio-intermediates unique to and characteristic of most cancer cell types. The addition of CPI-613® (devimistat) to high dose cytarabine and mitoxantrone (CHAM) will improve the complete remission (CR) rate in patients 50 years or older with relapsed or refractory AML when compared to HAM alone or other control sub groups.

Timeline

Start

2018-11-12

Primary completion

2021-10-25

Completion

2022-01-19

Publications

• Pardee TS, Powell BL, Larson RA, Maly J, Keng M, Foster M, Choi EJ, Sill H, Cluzeau T, Jeyakumar D, Frankfurt O, Patel P, Schuster M, Koller E, Costello R, Platzbecker U, Montesinos P, Vives S, Nazha A, Cook R, Vigil-Gonzales C, Chantepie S, Luther S, Cortes J. Devimistat plus chemotherapy vs chemotherapy alone for older relapsed or refractory patients with AML: results of the ARMADA trial. Blood Neoplasia. 2024 Mar 29;1(2):100009. doi: 10.1016/j.bneo.2024.100009. eCollection 2024 Jun.

Drugs

Indications