Acute Myeloid Leukemias
Conditions
Keywords
SNDX-5613, Nucleophosmin 1, NPM1, Acute Myeloid Leukemias, AML, Revumenib, Newly diagnosed AML
Brief summary
The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy.
Interventions
DRUGRevumenib
Participants will receive revumenib orally.
DRUGPlacebo
Participants will receive placebo (non-active agent) orally.
DRUGIntensive Chemotherapy Regimen
Participants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion.
Sponsors
Syndax Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Participants must have newly diagnosed and previously untreated AML and be candidates for intensive chemotherapy. * Presence of an NPM1 mutation. * Eastern Cooperative Oncology Group performance status ≤2 (≤1 if \>65 years old); 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
* Diagnosis of active acute promyelocytic leukemia. * Active central nervous system disease. * Fridericia's corrected QT interval (QTcF) \>450 milliseconds at screening, diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome. * Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion. * Any concurrent malignancy requiring active therapy (except breast or prostate cancer stable on or responding to endocrine therapy). * Inability to swallow oral medication. * Pregnant or nursing females. * Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection or human immunodeficiency virus (HIV)-positive with detectable viral load. Note: Additional inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event Free Survival | Up to 2 years |
| Measurable Residual Disease Complete Remission Rate | Up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | Up to 5 years |
| Rate of Complete Remission | Up to 2 years |
| Rate of Composite Complete Remission | Up to 2 years |
| Overall Response Rate | Up to 2 years |
| Duration of Complete Remission | Up to 2 years |
| Duration of Composite Complete Remission | Up to 2 years |
| Duration of Response | Up to 2 years |
| Number of Participants with a Treatment-emergent Adverse Event | Up to 2 years |
| Change from Baseline in Patient-reported Fatigue Questionnaire Scores | Up to 2 years |
Countries
Australia, Austria, Belgium, Brazil, Canada, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Lithuania, Malaysia, Romania, South Korea, Spain, United Kingdom, United States
Contacts
CONTACTSyndax Pharmaceuticals
Outcome results
None listed