A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients With IDH1-mutated Myeloid Malignancies
M.D. Anderson Cancer Center
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.
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…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of AML, MDS, MPN, or CMML according to World Health Organization (WHO) classification that underwent first or second alloSCT regardless of stem cell source, donor type/match, conditioning regimen, or GVHD prophylaxis and is at least 30 days post stem cell transplant until day 120. 2. Evdence of an IDH1 mutation presence by next generation sequencing panel at original diagnosis. 3. Evidence of engraftment by Absolute neutrophil count (ANC) \>/= 1.0x 109/L without daily use of myeloid growth factor (G-CSF) for at least 7 days; and Platelet \>/= 30 x 109/L with o…
Interventions
- DrugOlutasidenib
Given by mouth
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas