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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objectives To determine the overall response rate of olutasidenib in combination with investigator's choice of HMA in patients with IDH1-mutated higher-risk MDS/CMML or advanced MPN Secondary Objectives The secondary objectives of this study are: * To evaluate the rates of complete remission (CR) and median duration of CR * To ascertain the safety and tolerability of olutasidenib with HMA in this participant population * To determine survival including overall survival (OS), progression-free survival (PFS), and duration of response (DOR) To analyze reduction in IDH1 clone size Exploratory Objectives * To examine overall response rate of patients previously exposed to venetoclax * To investigate global gene expression profiles, DNA methylation profiles, and other potential prognostic markers to explore predictors of antitumor activity and/or resistance to treatment

Conditions

• Chronic Myelomonocytic Leukemia
• Advanced Myeloproliferative Neoplasms
• IDH1-mutated Higher-Risk Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Olutasidenib	Given by PO

Timeline

• Start date: 2025-01-28
• Primary completion: 2027-08-31
• Completion: 2029-08-31
• First posted: 2024-09-19
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study