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
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Diagnosed with AML, MDS, MPN, or CMML and undergone first or second allogeneic stem cell transplant 30 to 120 days prior
- Confirmed presence of IDH1 mutation at original diagnosis
- Evidence of engraftment with ANC 9= 1.0 x 10^9/L without daily growth factor use for at least 7 days
- Platelet count 9= 30 x 10^9/L without platelet transfusion within 1 week
- Morphologic remission with less than 5% blasts in bone marrow at Day +30
- Age between 18 and 75 years
- ECOG performance status 0, 1, or 2, or Karnofsky Performance Status above 70
- Creatinine clearance 9= 40 mL/min as calculated by Cockcroft-Gault Equation
- Serum bilirubin 9= 1.5 x upper limit normal except in Gilbert's Syndrome (bilirubin 9= 3.0 mg/dL)
- AST or ALT 9= 2.5 x upper limit normal
- Alkaline phosphatase 9= 2.5 x upper limit normal
- No active bleeding
- No life-threatening infection
- Able to understand study and provide informed consent
- Negative pregnancy test at screening for women with reproductive potential
- Female participants of non-childbearing potential meet specific criteria (postmenopausal, hysterectomy, ovarian failure, or surgical sterilization)
- Sexually active females of childbearing potential agree to use highly effective contraception during treatment and for 3 months after
- Male participants agree to use adequate contraception during and for 4 months after study treatment
You will not qualify if you...
- Use of other anti-leukemic maintenance therapies post-transplant prior to study
- Overall grade II-IV acute graft-versus-host disease (aGVHD); enrollment allowed if symptoms resolved to grade 1 or 0 and prednisone dose 9= 0.5 mg/kg daily or lower
- Moderate or severe chronic GVHD by NIH criteria
- Active uncontrolled systemic fungal, bacterial, or viral infections
- Known active HIV, HBV, or HCV infection; exceptions if HBV or HCV infection is controlled or resolved
- QTc interval > 480 milliseconds
- Any condition that investigator judges would contraindicate study participation
- Cognitive or psychiatric disorders interfering with safety, consent, or compliance
AI-Screening
AI-Powered Screening
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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
CONTACT
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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