Actively Recruiting
A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients With IDH1-mutated Myeloid Malignancies
Led by M.D. Anderson Cancer Center · Updated on 2026-03-04
31
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of olutasidenib as a maintenance therapy for patients with IDH1-mutated myeloid malignancies after they have received a stem cell transplant. This phase II open-label study aims to learn how patients respond to olutasidenib in the post-transplant setting and assess various outcomes including progression-free survival, overall survival, relapse rates, and graft versus host disease. Starting 30 to 120 days after stem cell infusion, participants take olutasidenib by mouth twice daily for 28 days per cycle. These cycles repeat every 28 days for up to two years unless the disease progresses or unacceptable side effects occur. During the study, patients may have blood samples taken regularly and may undergo bone marrow biopsies, heart scans (ECHO/MUGA), and chest x-rays at screening. Participants will be closely monitored through clinical evaluations and laboratory tests throughout the study period, which can last up to two years. Researchers will measure safety outcomes, adverse events, and disease progression. The study includes follow-up to observe relapse and survival rates, along with assessments for graft versus host disease. The total participation time averages about one year for safety monitoring, with ongoing evaluations during treatment cycles.
CONDITIONS
Brief Title
A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients With IDH1-mutated Myeloid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of AML, MDS, MPN, or CMML with IDH1 mutation confirmed by next generation sequencing
- Underwent first or second allogeneic stem cell transplant, 30 to 120 days prior to study start
- Evidence of engraftment with ANC ≥ 1.0 x 10^9/L without daily growth factor use for at least 7 days
- Platelet count ≥ 30 x 10^9/L without platelet transfusion in the past week
- Morphologic remission with less than 5% blasts in Day +30 bone marrow
- Age between 18 and 75 years
- ECOG performance status 0, 1, or 2 or Karnofsky Performance Status above 70
- Creatinine clearance ≥ 40 cc/min as per Cockcroft-Gault Equation
- Liver function tests within specified limits unless Gilbert's Syndrome present
- No active bleeding or life-threatening infection
- Able to provide informed consent
- Negative pregnancy test for women with reproductive potential
- Women of non-childbearing potential must meet specific criteria
- Use of effective contraception for participants of childbearing potential during and 3 months after treatment
- Men must use contraception during and 4 months after treatment
You will not qualify if you...
- Use of other anti-leukemic agents as maintenance therapy after transplant prior to study
- Overall grade II-IV acute graft versus host disease (aGVHD) unless resolved to grade 1 or 0
- Moderate or severe chronic graft versus host disease (cGVHD)
- Active uncontrolled systemic fungal, bacterial, or viral infection
- Known active HIV, Hepatitis B, or Hepatitis C infection unless controlled and stable
- QT prolongation with QTcF interval > 480 milliseconds
- Any condition deemed unsafe for participation by the investigator
- Cognitive impairments or psychiatric disorders interfering with consent or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years in the absence of disease progression or unacceptable toxicity
Participants receive olutasidenib orally twice daily on days 1-28 of each 28-day cycle as maintenance therapy after stem cell transplant.
Repeated 28-day cycles with ongoing blood sample collections
Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jeremy Ramdial, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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