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OncoMatch/Clinical Trials/NCT06575296

Revumenib for the Treatment of Acute Leukemia in Patients Post-Allogeneic Stem Cell Transplant

Is NCT06575296 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Revumenib for acute leukemia.

Phase 1RecruitingCity of Hope Medical CenterNCT06575296Data as of May 2026

Treatment: RevumenibThis phase I trial tests the safety, side effects, best dose and effectiveness of revumenib in treating patients with acute leukemia after allogeneic stem cell transplant. Revumenib is in a class of medications called menin inhibitors. Revumenib targets and binds to the protein menin, thereby preventing the interaction between menin and the mixed lineage leukemia protein. Disrupting this interaction prevents the activation of specific genes that fuel the development of leukemia cells and inhibits the survival, growth, and production of certain kinds of leukemia cells. Giving revumenib may be safe, tolerable, and/or effective in treating patients with acute leukemia after allogeneic stem cell transplant.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Biomarker criteria

Required: NPM1 mutation

Confirmed NPM1m AML with at least one of the following additional characteristics

Required: KMT2A (MLL) rearrangement

Confirmed KMT2Ar acute leukemia obtained by fluorescence in situ hybridization (11q23 MLL-break apart fluorescence in situ hybridization [FISH]) or next-generation sequencing (NGS)

Allowed: FLT3 ITD co-mutation

FLT3-ITD co-mutation

Performance status

ECOG/KARNOFSKY/LANSKY 0–2

ECOG =< 2 or Karnofsky Performance Status (KPS) >= 70, or a Lansky Performance Score of >= 70 (if aged < 18 years)

Prior therapy

Must have received: allogeneic stem cell transplant — scheduled or completed

PATIENTS WHO ARE SCHEDULED TO UNDERGO HEMATOPOIETIC CELL TRANSPLANTATION (HCT) OR THOSE WHO HAVE UNDERGONE HCT

Cannot have received:

Prior diagnosis of acute promyelocytic leukemia

Lab requirements

Blood counts

Hemoglobin >= 9 (no transfusion/growth factors to achieve); Platelets >= 75,000 (no transfusion/growth factors to achieve); ANC >= 500 for 3 days (fully engrafted, no GCSF to meet criteria)

Kidney function

Creatinine clearance >= 60 mL/min per 24 hour urine test or Cockcroft-Gault formula

Liver function

Total bilirubin <= 1.5 x ULN (<= 3.0 x ULN if < 75 years); AST <= 2.5 x ULN; ALT <= 2.5 x ULN

Cardiac function

QTcF <= 450 msec (males) or <= 470 msec (females); Ejection fraction (EF) >= 50% by echocardiogram or MUGA

Hemoglobin (Hgb) >= 9. Platelets >= 75 thousand (k). ANC >= 500 for 3 days. Total bilirubin <= 1.5 x ULN (<= 3.0 x ULN if < 75 years). AST <= 2.5 x ULN. ALT <= 2.5 x ULN. QTcF <= 450 msec (males) or <= 470 msec (females). Ejection fraction (EF) >= 50%. Creatinine clearance >= 60 mL/min.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope Medical Center · Duarte, California

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