NCT06668584

A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients With IDH1-mutated Myeloid Malignancies

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to learn about the safety and tolerability of giving olutasidenib to patients with IDH1-mutated myeloid malignancies as maintenance therapy after they receive a stem cell transplant.

Detailed description

Primary Objective: To determine the safety and tolerability of olutasidenib as maintenance post-alloSCT. Secondary Objectives: I. To determine the rate of progression-free survival (PFS) of patients with IDH1 mutated myeloid malignancies who have undergone a stem cell transplant on olutasidenib post-transplant. II. To determine response rate, overall survival (OS), cumulative incidence of relapse, non-relapse mortality (NRM), graft versus host disease (GVHD) relapse-free survival (GRFS), rate and grading of acute GVHD (aGVHD) grade 2-4 and 3-4 at day 100, incidence and grading chronic GVHD (cGVHD) all grades. OUTLINE: Starting 30-120 days post-stem cell infusion, patients receive olutasidenib orally (PO) twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study. Additionally, patients may undergo bone marrow aspiration and biopsy, echocardiography (ECHO)/multigated acquisition (MUGA) scan and chest x-ray at screening.

Conditions

• Myeloid Malignancies

Interventions

Type	Name	Description
DRUG	Olutasidenib	Given by mouth

Timeline

• Start date: 2024-12-31
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2024-10-31
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study