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Olutasidenib After Transplant for IDH1-Mutated Myeloid Cancers

This study is testing a drug called olutasidenib as a maintenance treatment after a stem cell transplant for people with myeloid malignancies (blood cancers) that have a specific gene change called IDH1-mutated. The main goal is to see how safe olutasidenib is and how well people tolerate it. You could be eligible if you are 18-75 years old, have one of these cancers with the IDH1 mutation, and had a stem cell transplant 30 to 120 days ago. The study aims to enroll 31 participants. The current recruitment status is unclear.

Study design
This is an open-label study, meaning you and your doctors will know you are receiving olutasidenib. It plans to enroll 31 participants.
What's involved
You would take olutasidenib by mouth twice daily for 28 days in each cycle, for up to 2 years. You will also have blood tests and may have bone marrow procedures, heart scans (ECHO/MUGA), and chest X-rays.
Compensation
Not stated in the trial record.
Follow-up
Your safety and side effects will be measured throughout the study, for an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06668584

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
M.D. Anderson Cancer Center
~31 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Olutasidenib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Myeloid Malignancies

Explore related trials

Acute Myeloid LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic SyndromeMyeloproliferative disorderIDH1 Gene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Jeremy Ramdial, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Jeremy Ramdial, MD
[email protected]
(713) 745-0146
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Patients with known active hepatitis B virus (HBV) infection will be excluded because of potential effects on immune function and/or drug interactions. However, if a patient has HBV history with an undetectable HBV load by polymerase chain reaction (PCR), no liver-related complications, and is on definitive HBV therapy that is not contraindicated in this study, then they would be eligible for study.
Patients with known active hepatitis C virus (HCV) infection will be excluded because of potential effects on immune function and/or drug interactions. However, if a patient with a history of HCV infection has received definitive therapy (and is now HCV viral load negative), or if a patient has a reactive HCV antibody test but has an undetectable viral load by PCR, then they would be eligible.
Patients with known active HIV infection will be excluded out of concern for the drug-drug interaction with venetoclax and highly active antiretroviral therapy (HART) 6. QT prolongation of corrected QTcF interval (QTc) \> 480 milliseconds 7. Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures. 8. Patients with cognitive impairments or psychiatric disorders that can interfere with safety or with obtaining informed consent of compliance with study procedures.

What this trial measures

  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0