Revumenib + Chemotherapy for Acute Myeloid Leukemia
(REVEAL-ND NPM1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether adding a new drug, revumenib, to standard chemotherapy can benefit people with acute myeloid leukemia (AML) who have an NPM1 mutation. The researchers aim to determine if this combination improves patient outcomes more than chemotherapy alone and to assess the safety of the new treatment. Suitable candidates for this trial include those recently diagnosed with AML, who have not yet received treatment, and have the NPM1 mutation. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that revumenib can be a safe treatment for certain types of acute myeloid leukemia (AML). Many patients responded well, and side effects were generally manageable. In one study, only a few patients stopped treatment due to side effects, which were mostly mild. The FDA has approved revumenib for AML with specific genetic mutations, indicating its general safety for humans. While some side effects may occur, they are usually not severe and can be managed.12345
Why do researchers think this study treatment might be promising for AML?
Revumenib is unique because it specifically targets a protein called menin, which plays a key role in the development of acute myeloid leukemia (AML). Unlike standard chemotherapy treatments that attack rapidly dividing cells indiscriminately, revumenib aims to disrupt the cancer's growth at a molecular level. Researchers are excited about revumenib because it offers a more targeted approach, potentially reducing side effects and improving outcomes for patients with AML.
What evidence suggests that this trial's treatments could be effective for acute myeloid leukemia?
Research has shown that revumenib may help treat acute myeloid leukemia (AML) in patients with certain genetic mutations. Studies have found that revumenib, whether used alone or with other treatments, can lead to high remission rates, meaning the cancer becomes less active or disappears. For instance, one study showed a 63.2% positive response rate in patients with specific genetic changes. Due to its effectiveness, the FDA has approved revumenib for AML with these mutations. In this trial, participants will receive either revumenib combined with an intensive chemotherapy regimen or a placebo with the same chemotherapy regimen. The success of revumenib in previous studies suggests it could be effective when combined with chemotherapy in this trial.24678
Are You a Good Fit for This Trial?
This trial is for people newly diagnosed with acute myeloid leukemia (AML) who have an NPM1 gene mutation. Participants must be healthy enough for intensive chemotherapy, have good liver, kidney, and heart function, and a life expectancy of at least 3 months.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive revumenib or placebo in combination with intensive chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Intensive Chemotherapy Regimen
- Revumenib
Trial Overview
The study compares standard intensive chemotherapy plus either revumenib or a placebo in people with AML and an NPM1 mutation. Patients are randomly assigned to receive either the new drug or placebo along with chemo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive revumenib plus an intensive chemotherapy regimen.
Participants will receive placebo plus an intensive chemotherapy regimen.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Syndax Pharmaceuticals
Lead Sponsor
Citations
Menin Inhibition With Revumenib for KMT2A-Rearranged ...
Overall response rate was 63.2% Revumenib led to high remission rates with a predictable safety profile in R/R KMT2Ar acute leukemia.
2.
ir.syndax.com
ir.syndax.com/news-releases/news-release-details/syndax-presents-positive-revuforjr-revumenib-data-acuteSyndax Presents Positive Revuforj® (revumenib) Data in ...
Positive data from multiple trials of Revuforj® (revumenib) as a single-agent and in combination with standard of care agents in patients with acute leukemias.
3.
oncologynewscentral.com
oncologynewscentral.com/drugs/info/fda-approves-revumenib-for-acute-myeloid-leukemia-with-susceptible-npm1-mutationFDA Approves Revumenib for Acute Myeloid Leukemia ...
The majority of patients had AML (86% in the efficacy population and 83% in the safety population) followed by acute lymphoblastic leukemia. ...
4.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/6065/527234/Efficacy-and-Safety-of-Revumenib-in-the-TreatmentEfficacy and Safety of Revumenib in the Treatment of Acute ...
The pooled analysis demonstrated a high Overall Response Rate (ORR) of 42% (95% CI: 34-51%) for Revumenib, with a complete remission (CR) rate ...
Revumenib Shows Efficacy in Patients With AML and ...
“The revumenib data in R/R mNPM1 AML presented at EHA are impressive, with 26% of patients achieving [complete remission/complete remission with ...
Early Data Show Revumenib Offers Maintenance Option in ...
This study reported a historical 2-year OS rate of 33% and 1-year cumulative relapse rate of 40% among patients with these genotypes who ...
7.
ir.syndax.com
ir.syndax.com/news-releases/news-release-details/syndax-announces-publication-pivotal-revumenib-data-relapsed-orSyndax Announces Publication of Pivotal Revumenib Data in ...
The median OS observed was 23.3 months (95% CI: 7.2-not reached) among the 15 CR+CRh responders based on the Kaplan-Meier estimate. The safety ...
8.
ashpublications.org
ashpublications.org/blood/article/146/9/1065/537139/Menin-inhibition-with-revumenib-for-NPM1-mutatedMenin inhibition with revumenib for NPM1-mutated relapsed ...
Revumenib exhibited a promising complete response rate and manageable safety profile in patients with NPM1m R/R AML. Responses were found across subgroups ...
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