Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant
NCT Number: NCT06543381
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Acute Myeloid Leukemia|Chronic Myelomonocytic Leukemia|Myelodysplastic Syndrome
Interventions: PROCEDURE: Biospecimen Collection|DRUG: Olutasidenib
Sponsor: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-05
Completion Date: 2027-02-05
Locations: City of Hope Medical Center, Duarte, California, 91010, United States|Cleveland Clinic Cancer Center, Cleveland, Ohio, 44195, United States

Summary:
This phase I trial tests the safety, side effects, and effectiveness of olutasidenib in preventing the return of disease (relapse) in patients who have undergone donor (allogeneic) hematopoietic cell transplant for acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML) carrying an IDH1 mutation. Olutasidenib is in a class of medications called IDH1 inhibitors. It works by slowing or stopping the growth of cancer cells. Giving olutasidenib may be safe, tolerable and/or effective in preventing relapse in patients with IDH1 mutated AML, MDS or CMML after an allogeneic hematopoietic cell transplant.

Primary Outcome Measures: Incidence of adverse events (AEs), AEs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0., Up to 30 days after last dose of study treatment|Proportion of patients completing at least 6 months of study therapy, Tolerability will be defined as the proportion of patients who complete at least 6 months of study therapy., Up to 2 years
Secondary Outcome Measures: Overall survival (OS), OS will be analyzed using the Kaplan-Meier method., From start of treatment to death, assessed up to 2 years|Leukemia-free survival (LFS), LFS will be analyzed using the Kaplan-Meier method., From start of treatment to relapse or death, assessed up to 2 years|Time to relapse, Time to relapse will be analyzed using the curves of cumulative incidence., From start of treatment to relapse, assessed up to 2 years|Non-relapse mortality (NRM), NRM will be analyzed using the curves of cumulative incidence., From start of treatment to death from causes other than relapse, assessed up to 2 years|Graft versus host disease (GVHD) free, relapse-free survival (GRFS), GRFS will be analyzed using the Kaplan-Meier method., From start of treatment to grade III or IV acute GVHD, chronic GVHD requiring systemic therapy, relapse, or death, assessed up to 2 years|Rate of acute GVHD (aGVHD) grades II-IV and III-IV, Rate of aGVHD will be graded according to Mount Sinai Acute Graft Versus Host Disease International Consortium Grading System grading., From transplant to aGVHD onset, assessed up to 2 years|Incidence of chronic GVHD (cGVHD), Incidence of cGVHD will be scored according to National Institutes of Health Consensus Staging and will be measured from start of protocol therapy to the documented/biopsy proven cGVHD onset date., From start of treatment to cGVHD onset, assessed up to 2 years