Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib
NCT06445959 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 78
Last updated 2026-05-20
Summary
To find a recommended combination dose of decitabine and venetoclax that can be given in combination with olutasidenib to participants with AML.
Conditions
- Mutant IDH1 Inhibitor Olutasidenib
Interventions
- DRUG
-
Olutasidenib
Given by PO
- DRUG
-
Given by PO
- DRUG
-
Decitabine
Given by IV
- DRUG
-
Decitabine/cedazuridine
Given by PO
Sponsors & Collaborators
-
Rigel Pharmaceuticals,Inc.
collaborator UNKNOWN -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Courtney DiNardo, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-29
- Primary Completion
- 2027-06-30
- Completion
- 2029-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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