Actively Recruiting
A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm
Led by M.D. Anderson Cancer Center · Updated on 2026-04-15
45
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
R
Rigel Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if olutasidenib, when combined with a drug called a hypomethylating agent (HMA) can help to control MDS, CMML, and/or MPN. The safety of the drug combination will also be studied.
CONDITIONS
Official Title
A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed higher-risk MDS, CMML, or advanced MPN
- MDS with IPSS intermediate-2 or high-risk, IPSS-R score ≥ 3.5, or IPSS-M moderate high to very high risk or bone marrow blasts
- CMML with CPSS-Mol intermediate-1, intermediate-2, or high-risk disease
- Advanced MPN defined by bone marrow blasts ≥ 10%
- Treatment-naive participants must not have received prior HMA; prior growth factors or hydroxyurea allowed
- Previously treated participants must have had prior HMA and/or ivosidenib; prior stem cell transplant allowed
- Documented IDH1 mutation
- Previously treated MDS patients must be ineligible for or have progressed on ivosidenib
- Age 18 years or older
- ECOG performance status 0 to 2
- Acceptable liver function: bilirubin ≤ 2x ULN or ≤ 3x ULN with Gilbert Syndrome; AST, ALT, alkaline phosphatase ≤ 3x ULN
- Acceptable kidney function with creatinine clearance ≥ 50 mL/min
- Negative pregnancy test if female of childbearing potential
- Agreement to use effective contraception during study and 90 days after last dose
- Ability and willingness to sign informed consent
You will not qualify if you...
- Unable to swallow oral medications or with gastrointestinal conditions affecting absorption
- Any uncontrolled significant medical condition or severe infection or psychiatric illness
- Prior chemotherapy must be stopped at least 1 week before starting study treatment
- MPN patients must be off JAK inhibitors at treatment start
- Active graft-versus-host disease post stem cell transplant, including chronic GVHD needing topical therapy
- Must have stopped calcineurin inhibitors at least 4 weeks before treatment
- Known active hepatitis B, hepatitis C, or HIV infection
- Pregnant or nursing women or women of childbearing potential not using effective contraception; men not using contraception
- White blood cell count greater than 25 x 10^9/L (hydroxyurea use allowed to meet this)
- Unable or unwilling to comply with study procedures or standard care
AI-Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
K
Kelly Chien, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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