OncoMatch/Clinical Trials/NCT06543381
Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant
Is NCT06543381 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Olutasidenib for acute myeloid leukemia.
Treatment: Olutasidenib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Required: IDH1 mutation
Performance status
ECOG OR KARNOFSKY 0–2
Prior therapy
Must have received: allogeneic hematopoietic cell transplantation
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
Cannot have received: more than one allogeneic HCT
Patients with more than one allogeneic HCT
Lab requirements
Blood counts
ANC > 1000/mm^3; Hemoglobin ≥ 8.0 gm/dL; Platelets ≥ 50,000/mm^3 (patients with lower counts can enroll if infection is being treated actively)
Kidney function
Creatinine clearance of ≥ 30/min/1.73 m^2 for participants with creatinine levels above institutional normal
Liver function
Bilirubin ≤ 2 x ULN (unless has Gilbert's disease); AST/ALT ≤ 2 x ULN; abnormal LFTs due to active GVHD not eligible
Cardiac function
Corrected QT interval (QTc) ≤ 480 ms
ANC > 1000/mm^3; Hemoglobin ≥ 8.0 gm/dL; Platelets ≥ 50,000/mm^3 (patients with lower counts can enroll if infection is being treated actively); Bilirubin ≤ 2 x ULN (unless has Gilbert's disease); AST/ALT ≤ 2 x ULN; abnormal LFTs due to active GVHD not eligible; Creatinine clearance of ≥ 30/min/1.73 m^2; QTc ≤ 480 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
- Cleveland Clinic Cancer Center · Cleveland, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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