Olutasidenib for IDH1-Mutated AML, MDS, or CMML After Transplant
This study is testing a drug called olutasidenib for people who have undergone a donor (allogeneic) stem cell transplant for acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML). This is for patients whose cancer has a specific change called an IDH1 mutation. Olutasidenib is an IDH1 inhibitor, meaning it works by slowing or stopping the growth of cancer cells with this mutation. The main goals are to see how safe olutasidenib is and if it can help prevent the cancer from coming back after transplant. Researchers will also look at how many patients complete at least 6 months of treatment. This study is currently unclear on its recruitment status and plans to enroll about 15 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is designed to evaluate the safety and effectiveness of olutasidenib in about 15 participants.
- What's involved
- You would take olutasidenib by mouth and provide blood samples for biospecimen collection. You would also need to agree to allow the use of archival tissue from diagnostic tumor biopsies.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure adverse events up to 30 days after your last dose of treatment and track the proportion of patients completing therapy for up to 2 years.
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NCT06543381
Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant
Recruiting
PHASE1Ages 18+InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~15 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:Biospecimen CollectionOlutasidenib
At a glance
Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs)
Measured over Up to 30 days after last dose of study treatment
+1 more outcome measured
Conditions
Where it's being run
2 sites across 2 statesCalifornia1
Ohio1
Study leadership
- Amandeep Salhotra, MD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
Eastern Cooperative Oncology Group (ECOG) ≤ 2 or Karnofsky performance status (KPS) ≥ 70
Patients who are scheduled to receive or have already undergone allogeneic hematopoietic cell transplantation (alloHCT) from any donor type, any conditioning regimen, and regardless of GVHD prophylaxis will be include
Patients must have AML, MDS, or CMML with mIDH1 diagnosis at diagnosis (regardless of time from HCT). Note: Patient with pre-HCT disease relapse will no be included if mIDH1 is not detected after relapse
Day 30 marrow post alloHCT should show evidence of morphologic remission with \< 5% bone marrow (BM) blasts. Patients with MRD-positive status either by flow cytometry or IDH1 mutation testing will be eligible
Patients with previous therapy with IDH1 inhibitors will be included
Absolute neutrophil count (ANC) \> 1000/mm\^3 (within 28 days prior to day 1 of protocol)
Hemoglobin ≥ 8.0 gm/dL (within 28 days prior to day 1 of protocol)
Platelets ≥ 50,000/mm\^3 (within 28 days prior to day 1 of protocol) Note: Patients with lower counts can enroll if infection cytomegalovirus (CMV)/human herpes virus 6 (HHV6), etc. is being treated actively
Bilirubin ≤ 2 x upper limit of normal (ULN) (within 28 days prior to day 1 of protocol) (unless has Gilbert's disease). Patients with abnormal liver function tests (LFTs) due to active GVHD will not be eligible
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2 x ULN (within 28 days prior to day 1 of protocol). Patients with abnormal LFTs due to active GVHD will not be eligible
Creatinine clearance of ≥ 30/min/1.73 m\^2 for participants with creatinine levels above institutional normal per 24 hour urine test or the Cockcroft-Gault formula (within 28 days prior to day 1 of protocol)
Corrected QT interval (QTc) ≤ 480 ms (Note: To be performed within 28 days prior to day 1 of protocol therapy)
Seronegative for HIV antigen/antibody (Ag/Ab) combo, hepatitis C virus (HCV) (if positive, hepatitis C ribonucleic acid \[RNA\] quantitation must be performed), active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin \[RPR\]) (within 28 days prior to day 1 of protocol)
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 28 days prior to day 1 of protocol). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Agreement by females and males of childbearing potential, defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only), to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy
Exclusion
Patients with more than one allogeneic HCT
History of allergic reactions attributed to compounds of similar chemical or biological composition to study agent
Active diarrhea considered clinically significant and may impair oral drug administration
Clinically significant uncontrolled illness
Uncontrolled infection requiring systemic antimicrobials
Active infection: Patients with treated viral, bacterial or fungal infections that are controlled on therapy will be allowed to participate
Participant has detectable human immunodeficiency virus (HIV) viral load within the previous 6 months (must have viral load testing prior to study enrollment if participant has a known history of HIV 1/2 antibodies)
Active hepatitis B or C, or HIV
Other active malignancy. Participants with history of prior malignancy treated with curative intent who achieved CR more than 2 years before study entry are eligible. This exclusion rule does not apply to non-melanoma skin tumors and in-situ cervical cancer
Females only: Pregnant or breastfeeding
Active grade II-IV acute GVHD per Mount Sinai Acute Graft Versus Host Disease International Consortium (MAGIC) criteria and/or requiring systemic steroids with prednisone dose equivalent of ≥ 0.25 mg/kg at end of 4 weeks. Patients with a mild form of acute GVHD involving skin, gut or liver requiring topical steroid creams or oral beclomethasone (8 mg/day), entocort, (9 mg/day) and/or solumedrol (and equivalent prednisone) will be allowed
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
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
What this trial measures
- Incidence of adverse events (AEs)Up to 30 days after last dose of study treatment
AEs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
- Proportion of patients completing at least 6 months of study therapyUp to 2 years
Tolerability will be defined as the proportion of patients who complete at least 6 months of study therapy.