SNDX-5613 for Acute Leukemia
(AUGMENT-101 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests revumenib (also known as SNDX-5613), a new treatment for acute leukemia, a type of blood cancer. The first part of the trial aims to find the optimal dose of revumenib that participants can tolerate. The second part examines the treatment's long-term effectiveness and safety. The trial seeks participants with active acute leukemia, specific genetic changes, and noticeable disease in their bone marrow. As a Phase 1/Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop all current medications. However, certain medications, especially those affecting the CYP3A4 enzyme, may affect eligibility. Participants in Phase 1 are grouped based on their use of specific CYP3A4 inhibitors or inducers. Additionally, there are specific washout periods for various treatments, such as 14 days for antileukemia therapy and 7 days for systemic glucocorticoids. It's best to discuss your current medications with the trial team to determine your eligibility.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that revumenib, the treatment under study, has a predictable safety profile. A safety evaluation involving 241 patients with acute leukemia, including both adults and children, found the treatment to be generally well-tolerated.
Earlier studies showed that revumenib led to promising remission rates in patients with a specific type of acute leukemia. The safety data from these studies suggested that side effects were manageable and expected. Although some patients experienced side effects, these were usually not severe.
This trial is still in the early stages, focusing on finding the right dose and assessing the treatment's safety. The fact that revumenib has been studied in many patients already provides some confidence in its safety. However, as with any trial, risks exist, and discussing these with the trial team is crucial.12345Why do researchers think this study treatment might be promising?
Researchers are excited about SNDX-5613, also known as revumenib, because it offers a novel approach to treating acute leukemia, particularly subtypes like KMT2Ar ALL/MPAL and NPM1m AML. Unlike standard chemotherapy treatments, which often target rapidly dividing cells indiscriminately, revumenib is designed to specifically inhibit the interaction of menin, a protein implicated in the development of certain leukemias. This targeted action could mean more effective treatment with potentially fewer side effects. Additionally, revumenib is administered orally, which is more convenient compared to many current treatments that require intravenous delivery.
What evidence suggests that SNDX-5613 might be an effective treatment for acute leukemia?
Research has shown that revumenib, the investigational treatment in this trial, holds promise for treating acute leukemia, particularly in patients with specific genetic changes known as KMT2A-rearranged or NPM1-mutated types. Studies have found that patients with relapsed or hard-to-treat acute leukemia responded well, with some achieving complete remission. Revumenib disrupts a protein interaction that contributes to certain leukemias. This targeted approach has proven safe and effective in various studies. Overall, early results suggest it could be a hopeful treatment for individuals with these specific types of leukemia.23567
Who Is on the Research Team?
Angela R Smith, M.D.
Principal Investigator
Syndax Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for individuals with relapsed/refractory acute leukemias, specifically those with MLL rearrangement or NPM1 mutation. Participants must have a white blood cell count below 25,000/microliter and resolved prior treatment toxicities to ≤Grade 1 (except neuropathy or alopecia). They should not be on certain antifungal drugs unless specified in the study arms, have no active central nervous system disease, HIV viral load, hepatitis B/C, significant cardiac issues within the last six months, severe gastrointestinal conditions affecting drug absorption or serious graft-versus-host disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Dose Escalation
Oral revumenib; sequential cohorts of escalating dose levels to identify the MTD and RP2D
Phase 2: Dose Expansion
Participants enrolled in 3 indication-specific expansion cohorts to determine efficacy, safety, and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SNDX-5613
Find a Clinic Near You
Who Is Running the Clinical Trial?
Syndax Pharmaceuticals
Lead Sponsor