Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies

This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with ivosidenib with or without azacitidine, in treating patients with IDH1-mutated hematologic malignancies. Venetoclax and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ivosidenib and venetoclax with azacitidine

Trial Details

NCT ID
NCT03471260
Phase
PHASE1 / PHASE2
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Azacitidine
  • Ivosidenib
  • Venetoclax
Locations (sample)
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Cleveland, Ohio, United States|41.4995,-81.69541
  • Portland, Oregon, United States|45.52345,-122.67621
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Age \> 18 years.
  • ECOG performance status of \< 2.
  • IDH1-R132 mutated disease status as assessed by local laboratory. 2HG-producing IDH1 variants outside of R132 (i.e. R100) may be eligible after dis…
  • Relapsed/refractory AML, or treatment-naïve patients with AML who are not eligible for standard induction chemotherapy. Patients with high-risk MDS…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Leukemia Trials on Trialify →