RecruitingPhase 2NCT06597734
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
Sponsor
M.D. Anderson Cancer Center
Enrollment
45 participants
Start Date
Jan 28, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study is testing the drug olutasidenib (which targets a specific genetic mutation called IDH1) in combination with standard hypomethylating agent chemotherapy in patients with higher-risk blood cancers — including myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), and advanced myeloproliferative neoplasms.
**You may be eligible if...**
- You are 18 or older
- You have been confirmed with higher-risk MDS, CMML, or advanced MPN
- Your cancer has a documented IDH1 mutation
- You are either treatment-naive (never had a hypomethylating agent) or have received prior treatment with those agents
- Your liver and kidney function meet the required thresholds
**You may NOT be eligible if...**
- You cannot swallow oral medications or have serious GI absorption issues
- You have active graft-versus-host disease from a prior stem cell transplant
- You have active hepatitis B, hepatitis C, or HIV
- You are pregnant or breastfeeding
- Your white blood cell count is above 25 x10^9/L (unless controlled by hydroxyurea)
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DRUGOlutasidenib
Given by PO
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06597734
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