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NCT06543381 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by City of Hope Medical Center.

Recruiting
Registry status
Phase 1
Development phase
15
Enrollment target
2
Study locations

NCT06543381 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 15 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT06543381, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is actively recruiting participants, sponsored by City of Hope Medical Center.

RECRUITING
Registry status
Phase 1
Development phase
15 participants
Enrollment target
2
Study locations

Study 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.

Conditions Studied

Acute Myeloid Leukemia Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia

Interventions

  • PROCEDURE Biospecimen Collection
  • DRUG Olutasidenib

Study Locations (2)

California

  • City of Hope Medical Center - Duarte

Ohio

  • Cleveland Clinic Cancer Center - Cleveland

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2025-01-17
Est. Completion 2027-02-05
Phase Phase 1

Sponsor

City of Hope Medical Center

582 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06543381

The ClinicalTrials.gov registry entry for NCT06543381 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (87% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Biospecimen Collection is the first listed.

NCT06543381 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Ohio.

Frequently Asked Questions

What is clinical trial NCT06543381 about?

NCT06543381 is a clinical study titled "Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant". 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 myelomonocyt...

What is the current status of trial NCT06543381?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2025-01-17. Estimated completion is 2027-02-05.

What conditions does trial NCT06543381 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia.

What interventions are being tested in trial NCT06543381?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Olutasidenib (DRUG).

Who is sponsoring clinical trial NCT06543381?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06543381 being conducted?

This trial has 2 study locations across California, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.