RecruitingPhase 1NCT06543381

Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant

Pilot Trial of Olutasidenib Maintenance Post Allogeneic Hematopoietic Cell Transplantation in Patients Carrying IDH1 Mutation With AML, MDS, or CMML Disease


Sponsor

City of Hope Medical Center

Enrollment

15 participants

Start Date

Jan 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial tests the safety, side effects, and effectiveness of olutasidenib in preventing the return of disease (relapse) in patients who have undergone donor (allogeneic) hematopoietic cell transplant for acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML) carrying an IDH1 mutation. Olutasidenib is in a class of medications called IDH1 inhibitors. It works by slowing or stopping the growth of cancer cells. Giving olutasidenib may be safe, tolerable and/or effective in preventing relapse in patients with IDH1 mutated AML, MDS or CMML after an allogeneic hematopoietic cell transplant.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called olutasidenib for people with certain blood cancers — acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML) — that carry a specific gene mutation called IDH1, and who have had or are about to have a stem cell transplant from a donor. **You may be eligible if...** - You are 18 or older with AML, MDS, or CMML that has the IDH1 mutation - You have had or are scheduled to have a donor stem cell transplant - You are in reasonably good health (ECOG ≤ 2 or Karnofsky ≥ 70) **You may NOT be eligible if...** - Your IDH1 mutation was not detected at the time of your diagnosis - You had a disease relapse before transplant without a detectable IDH1 mutation - You have active graft-versus-host disease after your transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

DRUGOlutasidenib

Given PO


Locations(2)

City of Hope Medical Center

Duarte, California, United States

Cleveland Clinic Cancer Center

Cleveland, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT06543381


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