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OncoMatch/Clinical Trials/NCT06440135

Ziftomenib Maintenance Post Allo-HCT

Is NCT06440135 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Ziftomenib for acute myeloid leukemia.

Phase 1RecruitingMassachusetts General HospitalNCT06440135Data as of May 2026

Treatment: ZiftomenibThe purpose of this study is to test the safety, effects, and recommended dose of an investigational drug, ziftomenib, in addition to the standard treatment on blood cancer with Allogeneic Hematopoietic Cell Transplantation (allo-HCT). This study plans to learn more about ziftomenib, which targets and inhibits negative interactions within cancer cells related to AML, when given after allo-HCT, to determine if it improves outcomes following allo-HCT. The name of the study drug involved in this study is: • Ziftomenib

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: KMT2A (MLL) rearrangement

Required: NPM1 mutation

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: allogeneic hematopoietic cell transplant — first

Will undergo first allogeneic HCT for their malignancy

Cannot have received: menin inhibitor

Exception: permitted unless AML relapse or progression occurred while on menin inhibitor prior to transplant

Treatment with a menin inhibitor prior to transplant is permitted. However, patients who experienced AML relapse or progression while being treated with a menin inhibitor prior to transplant are ineligible.

Lab requirements

Kidney function

Calculated creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula)

Liver function

AST (SGOT), ALT (SGPT) and Alkaline phosphatase < 3x institutional ULN; Total bilirubin < 1.5 x institutional ULN (except Gilbert's syndrome < 5 x ULN)

Cardiac function

LVEF must be ≥50%, as measured by MUGA scan or echocardiogram

Participants must have normal organ and function as defined below: AST (SGOT), ALT (SGPT) and Alkaline phosphatase < 3x institutional upper limit of normal (ULN); Total bilirubin < 1.5 x institutional ULN (with the exception of subjects with a history of Gilbert's syndrome, for which the total bilirubin must be < 5 x ULN); Calculated creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula); LVEF must be ≥50%, 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
  • Ohio State University Wexner Medical Center- James Cancer Hospital · Columbus, Ohio

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