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New treatment option for Acute Myeloid Leukemias
Official title Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
ClinicalTrials.gov ID: NCT07211958
What this study is testing
What is Revumenib?
Revumenib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute myeloid leukemias.
Also referred to as SNDX-5613.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
- Gosford, Australia
- Wollongong, Australia
- Linz, Austria
- Ghent, Belgium
- Jaú, Brazil
- Porto Alegre, Brazil
- Montreal, Canada
- Toronto, Canada
- Bayonne, France
- Bordeaux, France
- Batumi, Adjara, Georgia
- Tbilisi, Georgia
- Düsseldorf, North Rhine-Westphalia, Germany
- Herne, North Rhine-Westphalia, Germany
- Jena, Thuringia, Germany
- Hamburg, Germany
- Jerusalem, Israel
- Bergamo, Italy
- Candiolo, Italy
+ 25 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia; Gosford, Australia; Wollongong, Australia; Linz, Austria; Ghent, Belgium; Jaú, Brazil and 39 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.