OncoMatch/Clinical Trials/NCT06707493
Ivosidenib as Post-HSCT Maintenance for AML
Is NCT06707493 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Ivosidenib for idh1 mutation.
Treatment: Ivosidenib — This is a Phase 2 study of the study drug, ivosidenib (a mutant IDH1 inhibitor), compared to placebo, given to patients with IDH1-mutant acute myeloid leukemia (AML) after hematopoietic stem cell transplantation (HCT).
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: IDH1 r132 mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: hematopoietic stem cell transplant — allogeneic
Will undergo allogeneic hematopoietic stem cell transplantation (HSCT) for their malignancy.
Cannot have received: allogeneic hematopoietic stem cell transplant
Prior allogeneic hematopoietic stem cell transplants.
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1000/µL without growth factor support in the previous 7 days; Platelet count ≥ 50,000/µL without transfusional support in the previous 7 days
Kidney function
Calculated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula)
Liver function
AST (SGOT), ALT (SGPT) and Alkaline phosphatase < 3x institutional upper limit of normal (ULN); Direct bilirubin < 2.0 mg/dL
Cardiac function
LVEF must be equal to or greater than 40%, as measured by MUGA scan or echocardiogram
Participants must have normal organ and marrow function as defined below: - Absolute neutrophil count ≥ 1000/µL without growth factor support (e.g. GCSF) in the previous 7 days. - Platelet count ≥ 50,000/µL without transfusional support in the previous 7 days. - AST (SGOT), ALT (SGPT) and Alkaline phosphatase < 3x institutional upper limit of normal (ULN) - Direct bilirubin < 2.0 mg/dL - Calculated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula) LVEF must be equal to or greater than 40%, as measured by MUGA scan or echocardiogram
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Massachusetts General Hospital · Boston, Massachusetts
- Dana Farber Cancer Institute · Boston, Massachusetts
- Froedtert Hospital & the Medical College of Wisconsin · Milwaukee, Wisconsin
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