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NCT06597734
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
Conditions: Chronic Myelomonocytic Leukemia, Advanced Myeloproliferative Neoplasms, IDH1-mutated Higher-Risk Myelodysplastic Syndromes
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Sponsor: M.D. Anderson Cancer Center
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 Criteria
Inclusion Criteria:
1. Pathologically proven higher-risk MDS/CMML or advanced MPN
1. 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.
2. CMML patients must have CPSS-Mol int-1, int-2, or high-ris disease (Elena C et al, Blood 2016)
3. Advanced MPN is defined as bone marrow blast percentage \>=/=10%.
4. 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.
5. Patients on the previously-treated arm must have received a prior HMA and/or ivosidenib. Prior stem cell transplantation in allowed\>
2. Participants must have a documented IDH1 mutation
3. Patients with previously-treated MDS must be ineligible to receive treatment with ivosidenib or have progressed on treatment with ivosidenib.
4. Participants \>=/= 18 years old
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Appendix A)
6. Acceptable liver function
1. Bilirubin \
Source: ClinicalTrials.gov (NCT06597734). StuddyBuddy aggregates publicly available trial information.