RECRUITINGPhase 3INTERVENTIONAL
Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed AML With an NPM1 Mutation
About This Trial
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.
Who May Be Eligible (Plain English)
Key Who May Qualify:
- 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 Who Should NOT Join This Trial:
- 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 weakened immune system virus (HIV)-positive with detectable viral load.
Note: Additional inclusion/exclusion criteria may apply, per protocol.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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/exclusion criteria may apply, per protocol.
Treatments Being Tested
DRUG
Revumenib
Participants will receive revumenib orally.
DRUG
Placebo
Participants will receive placebo (non-active agent) orally.
DRUG
Intensive Chemotherapy Regimen
Participants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion.
Locations (9)
Clinical Trial Site
Batumi, Adjara, Georgia
Clinical Trial Site
Tbilisi, Georgia
Clinical Trial Site 1
Tbilisi, Georgia
Clinical Trial Site 2
Tbilisi, Georgia
Clinical Trial Site
Tbilisi, Georgia
Clinical Trial Site
Jerusalem, Israel
Clinical Trial Site
Goyang-si, South Korea
Clinical Trial Site
Seoul, South Korea
Clinical Trial Site
Seoul, South Korea