Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Myeloid Leukemia
  • IDH2 Gene Mutation
  • Refractory Cancer
  • Relapsed Cancer
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: N/AIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

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...

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).

Tracking Information

NCT #
NCT04092179
Collaborators
  • Celgene
  • AbbVie
Investigators
Principal Investigator: Steven Chan, M.D. Princess Margaret Cancer Centre