Olutasidenib for IDH1 Mutated AML, MDS, or CMML

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

Recruiting Phase 1 Interventional Study
Acute Myeloid Leukemia Chronic Myelomonocytic Leukemia Myelodysplastic Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
City of Hope Medical Center · Other
Who this trial is looking for

This trial is looking for patients who have acute myeloid leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia that has an IDH1 mutation and have undergone a specific type of transplant. Participants will take a medication called olutasidenib to see if it helps prevent their disease from coming back.

Are You a Good Fit for This Trial?
Rules you out Active hepatitis BActive hepatitis CActive HIV

You may be able to join if

  • I am at least 18 years old
  • I have been diagnosed with AML, MDS, or CMML with an IDH1 mutation
  • I have had a donor stem cell transplant
  • I agree to let researchers use my past biopsy tissue for study
  • I have a good performance status (ECOG 0-2 or KPS ≥ 70)
  • I have enough healthy white blood cells, hemoglobin, and platelets
  • My bone marrow shows less than 5% cancer cells after transplant
  • I can provide informed consent

You may not be able to join if

  • I have had more than one donor stem cell transplant
  • I have a history of allergic reactions to similar medications
  • I have uncontrolled infections
  • I have other active cancers
  • I am currently pregnant or breastfeeding
  • I have severe acute graft-versus-host disease
  • I have had a detectable HIV viral load in the last 6 months
  • I am unable to comply with study procedures

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with study principal investigator (PI) approval * Age: ≥ 18 years *…
Contacts

Amandeep Salhotra, MD

1-626-359-8111

asalhotra@coh.org

CONTACT