OncoMatch/Clinical Trials/NCT06177067
Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
Is NCT06177067 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments for refractory acute myeloid leukemia.
Treatment: Revumenib · Venetoclax · Azacitidine · intrathecal (IT) chemotherapy · Cytarabine · Methotrexate — This is a research study to find out if adding a new study drug called revumenib to commonly used chemotherapy drugs is safe and if they have beneficial effects in treating patients with acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (ALAL) that did not go into remission after treatment (refractory) or has come back after treatment (relapsed), and to determine the total dose of the 3-drug combination of revumenib, azacitidine and venetoclax that can be given safely in participants also taking an anti-fungal drug. Primary Objective * To determine the safety and tolerability of revumenib + azacitidine + venetoclax in pediatric patients with relapsed or refractory AML or ALAL. Secondary Objectives * Describe the rates of complete remission (CR), complete remission with incomplete count recovery (CRi), and overall survival for patients treated with revumenib + azacitidine + venetoclax at the recommended phase 2 dose (RP2D).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: KMT2A (MLL) rearrangement
Presence of KMT2A rearrangement (KMT2Ar)
Required: NUP98 rearrangement
NUP98 rearrangement (NUP98r)
Required: NPM1 mutation
NPM1 mutation or fusion
Required: NPM1 fusion
NPM1 mutation or fusion
Required: PICALM PICALM::MLLT10 fusion
PICALM::MLLT10
Required: DEK DEK::NUP214 fusion
DEK::NUP214
Required: UBTF UBTF-TD
UBTF-TD
Required: KAT6A rearrangement
KAT6A rearrangement (KAT6Ar)
Required: SET SET::NUP214 fusion
SET::NUP214
Demographics
Prior therapy
Must have received: induction chemotherapy
persistent leukemia after at least two courses of induction chemotherapy (one course for secondary AML), or relapsed leukemia
Lab requirements
Kidney function
calculated creatinine clearance ≥60 mL/min/1.73 m^2
Liver function
total bilirubin < 1.5 × institutional upper limit of normal for age or normal conjugated bilirubin (for patients with known Gilbert's syndrome, total bilirubin <3 × the ULN) unless attributed to leukemia
Cardiac function
left ventricular ejection fraction ≥ 40%
Adequate organ function, defined as total bilirubin < 1.5 × institutional upper limit of normal for age or normal conjugated bilirubin (for patients with known Gilbert's syndrome, total bilirubin <3 × the ULN) unless attributed to leukemia, calculated creatinine clearance ≥60 mL/min/1.73 m^2, and left ventricular ejection fraction ≥ 40%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Rady Children's Hospital · San Diego, California
- Children's Hospital Colorado · Aurora, Colorado
- Children's Healthcare of Atlanta · Atlanta, Georgia
- Children's Mercy Hospital of Kansas City · Kansas City, Missouri
- Memorial Sloan- Kettering Cancer Center · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06177067 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received induction chemotherapy.
Does this trial require KMT2A?
Yes, KMT2A rearrangement is a required biomarker for enrollment.
Does this trial require NUP98?
Yes, NUP98 rearrangement is a required biomarker for enrollment.
Does this trial require NPM1?
Yes, NPM1 mutation is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 30 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify