Study of Enasidenib and Venetoclax in IDH2-Mutated Blood Cancers

Official Title

Phase Ib/II Study of IDH2 Inhibitor Enasidenib in Combination With BCL2 Inhibitor Venetoclax in Patients With IDH2-Mutated Myeloid Malignancies (ENAVEN-AML)

Summary:

The purpose of this research study is to see how safe and tolerable, and to find the highest or best dose, of an investigational combination of drugs called enasidenib and venetoclax, in patients with relapsed (the cancer has come back) or refractory (the cancer does not respond or have stopped responding to treatment) acute myeloid leukemia (AML, a type of blood cancer). This study will also see how useful the combination of enasidenib and venetoclax is in the treatment of patients with relapsed or refractory AML.

Trial Description

Primary Outcome:

• Overall response rate (ORR)
• Dose Limiting Toxicity
• Maximum tolerated dose or Recommended Phase 2 Dose
• Duration of Response

Secondary Outcome:

• Overall Survival
• Event Free Survival

This study will have two parts: Phase 1b and Phase 2. The part that patients may participate in will depend on when they join the study. In the phase 1b portion of the study, small groups participants will receive increasing doses of venetoclax in combination with a flat dose of enadisenib until the highest dose or best dose of venetoclax that is safe and tolerable in combination with enadisenib is found. In the phase 2 portion of the study, an additional group of participants will receive the highest or best dose of venetoclax found in the Phase 1b portion of the study with a flat dose of enadisenib to see how useful the combination is in treating relapsed or refractory acute myeloid leukemia (AML).

View this trial on ClinicalTrials.gov