Actively Recruiting
Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant
Led by City of Hope Medical Center · Updated on 2026-03-05
15
Participants Needed
2
Research Sites
107 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legally authorized representative has given documented informed consent
- Agreement to allow use of archival tissue from diagnostic tumor biopsies or approval of exception by study PI
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 or Karnofsky performance status 70 or higher
- Scheduled to receive or has received allogeneic hematopoietic cell transplantation from any donor type and conditioning regimen
- Diagnosis of AML, MDS, or CMML with mutated IDH1 at diagnosis
- Day 30 post-transplant bone marrow showing morphologic remission with less than 5% blasts; MRD-positive patients eligible
- Previous therapy with IDH1 inhibitors allowed
- Absolute neutrophil count greater than 1000/mm3 within 28 days prior to protocol start
- Hemoglobin 8.0 gm/dL or higher within 28 days prior to protocol start
- Platelets 50,000/mm3 or higher within 28 days prior to protocol start; lower counts allowed if infection is actively treated
- Bilirubin less than or equal to twice upper limit of normal within 28 days prior to protocol start, unless Gilbert's disease
- AST and ALT less than or equal to twice upper limit of normal within 28 days prior to protocol start; patients with LFT abnormalities due to active GVHD excluded
- Creatinine clearance 30 or higher (ml/min/1.73 m2) within 28 days prior to protocol start
- Corrected QT interval 480 ms or less within 28 days prior to protocol start
- Seronegative for HIV, active hepatitis B, hepatitis C, and syphilis within 28 days prior to protocol start
- Women of childbearing potential must have negative pregnancy test within 28 days prior to protocol start
- Agreement by males and females of childbearing potential to use effective birth control or abstain from heterosexual activity during the study and for 3 months after the last dose
You will not qualify if you...
- More than one prior allogeneic hematopoietic cell transplant
- History of allergic reactions to compounds similar to olutasidenib
- Active diarrhea that may impair oral drug administration
- Clinically significant uncontrolled illness
- Uncontrolled infection requiring systemic antimicrobials
- Detectable HIV viral load within 6 months prior to enrollment
- Active hepatitis B or C infection
- Other active malignancy except non-melanoma skin tumors or in-situ cervical cancer unless treated with curative intent and in remission for over 2 years
- Pregnant or breastfeeding females
- Active grade II-IV acute graft-versus-host disease requiring systemic steroids at specified doses
- Any other condition that contraindicates participation due to safety concerns
- Inability to comply with all study procedures according to investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Cleveland Clinic Cancer Center
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
Research Team
A
Amandeep Salhotra, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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