Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed KMT2Ar or NUP98r AML (REVEAL-ND KMT2A)
Not Applicable
Not yet recruiting
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Registration Number
- NCT07212023
- Lead Sponsor
- Syndax Pharmaceuticals
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 235
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Revumenib + Intensive Chemotherapy Revumenib Participants will receive revumenib plus an intensive chemotherapy regimen. Revumenib + Intensive Chemotherapy Intensive Chemotherapy Regimen Participants will receive revumenib plus an intensive chemotherapy regimen. Placebo + Intensive Chemotherapy Intensive Chemotherapy Regimen Participants will receive placebo plus an intensive chemotherapy regimen. Placebo + Intensive Chemotherapy Placebo Participants will receive placebo plus an intensive chemotherapy regimen.
- Primary Outcome Measures
Name Time Method Event-free Survival (EFS) Up to approximately 2 years
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) Up to approximately 2 years Complete Remission (CR) Rate Up to approximately 2 years Composite Complete Remission (CRc) Rate Up to approximately 2 years Duration of CR Up to approximately 2 years Duration of CRc Up to approximately 2 years Duration of Response (DOR) Up to approximately 2 years Overall Survival (OS) Up to approximately 5 years Measurable Residual Disease Complete Remission Rate Up to approximately 2 years Number of Participants with a Treatment-emergent Adverse Event (TEAE) Up to approximately 2 years Change from Baseline in Patient-reported Fatigue Questionnaire Scores Up to 2 years