A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients Wi… (NCT06597734) | Clinical Trial Compass
RecruitingPhase 2
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
United States45 participantsStarted 2025-01-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Pathologically proven higher-risk MDS/CMML or advanced MPN
✓. MDS participants must have International Prognostic Scoring System (IPSS) intermediate-2- or high-risk disease or Revised IPSS (IPSS-R) score \>= 3.5 or Molecular IPSS (IPSS-M) moderate high-, high-, or very high-risk disease or bone marrow blast percentage.
✓. CMML patients must have CPSS-Mol int-1, int-2, or high-ris disease (Elena C et al, Blood 2016)
✓. Advanced MPN is defined as bone marrow blast percentage \>=/=10%.
✓. Participants on the treatment-naive arm must not have received a prior HMA. Agents such as growth factors (e.g. erythropoietin stimulating agents, luspatercept, eltrombopag, granulocyte colony stimulating factors), cyclosporine, and/or hydroxyurea are allowed.
✓. Patients on the previously-treated arm must have received a prior HMA and/or ivosidenib. Prior stem cell transplantation in allowed\>
✓. Participants must have a documented IDH1 mutation
✓. Patients with previously-treated MDS must be ineligible to receive treatment with ivosidenib or have progressed on treatment with ivosidenib.
Exclusion criteria
✕. Participants unable to swallow oral medications, or participants with gastrointestinal conditions (e.g., malabsorption, resection, etc.) deemed by the Investigator to jeopardize intestinal absorption
✕. Participants with any concurrent uncontrolled clinically significant medical condition, including life-threatening severe infection or psychiatric illness, which could place the participant at unacceptable risk of study treatment
What they're measuring
1
Safety and adverse events (AEs)
Timeframe: Through study completion; an average of 1 year.
✕. Patients must have discontinued prior chemotherapy at least 1 week prior to the start of study treatment. Patients with MPN must be off JAK inhibitors at the start of study treatment
✕. Patients with active graft-versus-host-disease (GVHD) status post stem cell transplantation, including active chronic GVHD requiring topical therapy. Patients must have discontinued calcineurin inhibitors at least 4 weeks prior to the start of study treatment
✕. Known active hepatitis B (HBV) or hepatitis C (HCV) or HIV infection
✕. Pregnant or nursing women or women of childbearing potential not using highly effective contraception; male participants not using highly effective contraception
✕. Participants with white blood cell count \> 25 x109/L Note: hydroxyurea use is permitted to meet this criterion
✕. Unwillingness or inability to comply with procedures either required in this protocol or considered standard of care