Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed KMT2Ar or NUP98r AML (REVEAL-ND KMT2A)

Syndax Pharmaceuticals

Status and phase: Not yet enrolling; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Placebo; Drug: Revumenib; Drug: Intensive Chemotherapy Regimen

Study type: Interventional

Funder types: Industry

Identifiers

NCT07212023

SNDX-5613-0711

2025-522218-21-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with acute myeloid leukemia (AML) with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy

Enrollment: 235 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Participants must weigh ≥ 40 kilograms (kg).
• Participants must have newly diagnosed and previously untreated AML and be candidates for intensive induction chemotherapy.
• Presence of a KMT2A rearrangement or NUP98 rearrangement.
• Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2, or Karnofsky or Lansky ≥ 40.
• Have a life expectancy of ≥3 months as judged by the Investigator.
• Negative serum pregnancy test.
• Adequate liver, kidney, and cardiac function.

Key Exclusion Criteria:

• Not a candidate for anthracycline based therapy for Induction.
• Not a candidate for continuous infusion cytarabine during Induction or intermediate dose cytarabine for Consolidation.
• Diagnosis of active acute promyelocytic leukemia.
• Active central nervous system (CNS) disease (cytologic, such as any blasts on cytospin, or radiographic).
• QTc using Fridericia's correction (QTcF) > 450 milliseconds (msec) at Screening or history of long QT Syndrome.
• Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion (for example, gastric bypass, gastroparesis, etc).
• Any uncontrolled active infection.
• Any concurrent malignancy requiring active therapy (except breast or prostate cancer stable on or responding to endocrine therapy).

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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235 participants in 2 patient groups, including a placebo group

Revumenib + Intensive Chemotherapy

Experimental group

Description:

Participants will receive revumenib plus an intensive chemotherapy regimen.

Treatment:

Drug: Intensive Chemotherapy Regimen

Drug: Revumenib

Placebo + Intensive Chemotherapy

Placebo Comparator group

Description:

Participants will receive placebo plus an intensive chemotherapy regimen.

Treatment:

Drug: Intensive Chemotherapy Regimen

Drug: Placebo