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

Sex: All

Ages: 18 Years – 75 Years

Healthy volunteers: No

Phase: PHASE2

Enrollment: 31

Sponsor: M.D. Anderson Cancer Center

Location: The University of Texas M. D. Anderson Cancer Center Houston Texas

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.

Eligibility Criteria

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 out platelet transfusion within 1 week. 4. Patient in morphologic remission with Day +30 bone marrow \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06668584). StuddyBuddy aggregates publicly available trial information.