Actively Recruiting
Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib
Led by M.D. Anderson Cancer Center · Updated on 2026-04-08
78
Participants Needed
2
Research Sites
252 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
R
Rigel Pharmaceuticals,Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
To find a recommended combination dose of decitabine and venetoclax that can be given in combination with olutasidenib to participants with AML.
CONDITIONS
Official Title
Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Documented IDH1 gene mutation
- Diagnosis of relapsed or refractory AML (including biphenotypic or bilineage leukemia with a myeloid component or isolated extramedullary AML), or high-risk MDS by IPSS-R or IPSS-M
- Newly diagnosed AML patients not eligible or appropriate for intensive chemotherapy (Phase 2 only)
- Not eligible for intensive chemotherapy defined as age 75 or older, or age 18 to 74 with at least one severe cardiac disorder, severe pulmonary disorder, creatinine clearance 30 to less than 45 mL/min, moderate hepatic impairment, ECOG performance status of 2 or 3, or other comorbidities making intensive chemotherapy inappropriate
- ECOG performance status of 2 or less (unless age 18 to 74 with newly diagnosed AML not eligible for intensive chemotherapy)
- Adequate renal function with creatinine less than 1.5 unless related to disease or qualifying comorbid condition
- Adequate hepatic function with direct bilirubin less than 2x upper limit of normal unless due to Gilbert's disease or leukemic involvement; AST/ALT less than 3x upper limit of normal unless due to leukemic involvement
- At least 14 days from prior treatment to study start, except for allowed hydroxyurea or cytarabine use for rapidly proliferative disease
- Male participants sexually active with women of childbearing potential must agree to use barrier contraception and avoid sperm donation during and 90 days after treatment
- Willing and able to provide informed consent
You will not qualify if you...
- Presence of t(15;17) karyotypic abnormality or acute promyelocytic leukemia (FAB class M3-AML)
- Any uncontrolled clinically significant medical condition including severe infection or psychiatric illness posing unacceptable risk
- Active, uncontrolled leukemia involvement of the central nervous system
- Active graft-versus-host disease post stem cell transplant including active cGVHD requiring topical therapy; must have stopped calcineurin inhibitors at least 4 weeks before study
- Severe gastrointestinal or metabolic conditions interfering with oral medication absorption
- Known active hepatitis B or C infection or HIV infection
- White blood cell count greater than 25 x 10^9/L (hydroxyurea or cytarabine use allowed to meet this criterion)
- Nursing women, women of childbearing potential with positive pregnancy test, or women not willing to use adequate contraception
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Roswell Park
Buffalo, New York, United States, 14263
Actively Recruiting
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Courtney DiNardo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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