Bone Marrow Transplant Clinical Trial - Rafael Pharmaceuticals Inc. AML003

Status:

Open (Study open and enrolling)

ClinicalTrials.gov:

NCT03504410

 CONDITION(S): Relapsed/Refractory Acute Myeloid Leukemia - TRIAL: Rafael Pharmaceuticals Inc. AML003 - Study Evaluating Efficacy and Safety of CPI-613 in Combination With HD Cytarabine and Mitoxantrone vs HD Cytarabine and Mitoxantrone in Older Patients With R/R AML    

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 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.

Drug

CPI-613 + High Dose Cytarabine and MitoxantroneDrug: High Dose Cytarabine and Mitoxantrone

Trial Type

Interventional

Phase

Phase 3

Condition

Relapsed/Refractory Acute Myeloid Leukemia

Keywords

Rafael Pharmaceuticals Inc. AML003