Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib
M.D. Anderson Cancer Center
Summary
To find a recommended combination dose of decitabine and venetoclax that can be given in combination with olutasidenib to participants with AML.
Description
Primary Objectives * Phase 1b: To determine the safety and tolerability and recommended phase 2 dose (RP2D) of decitabine (either IV or oral decitabine/cedazuridine (ASTX727, Inqovi)) and venetoclax in combination with olutasidenib. * Phase 2: To determine the composite remission rate (CR, CRh and CRi) of decitabine (IV or oral decitabine/cedazuridine (ASTX727, Inqovi)) and venetoclax in combination with olutasidenib for newly diagnosed (Arm A) or relapsed/refractory (Arm B) participants with IDH1-mutated myeloid malignancy. Secondary Objectives * To determine duration of response (DOR), ev…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age \> 18 years 2. Participants must have a documented IDH1 gene mutation 3. Participants with a diagnosis of relapsed or refractory AML (including biphenotypic or bilineage leukemia including a myeloid component or isolated extramedullary AML), high-risk MDS by IPSS-R or IPSS-M; OR 4. Participants with newly diagnosed AML not eligible or appropriate for intensive chemotherapy are also eligible. (Phase 2 portion only) 5. To be considered not eligible for intensive chemotherapy, participants must be defined by the following: Age 75 years or older, or Age 18 to 74 years w…
Interventions
- DrugOlutasidenib
Given by PO
- DrugVenetoclax
Given by PO
- DrugDecitabine
Given by IV
- DrugDecitabine/cedazuridine
Given by PO
Locations (2)
- Roswell ParkBuffalo, New York
- MD Anderson Cancer CenterHouston, Texas