SNDX-5613 + Chemotherapy for Acute Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for patients with acute myeloid leukemia (AML) who have specific genetic changes. It tests the safety and optimal dose of a drug called SNDX-5613 (also known as Revumenib or Revuforj) when combined with standard chemotherapy drugs, daunorubicin and cytarabine. The aim is to determine if adding SNDX-5613 can shrink or stabilize the cancer more effectively than chemotherapy alone. This trial targets patients with newly diagnosed AML who haven't received prior treatment, except for a specific drug to manage high white blood cell counts. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but you cannot have received strong or moderate CYP3A4 inhibitors or inducers within 7 days of enrollment. It's important to discuss your current medications with the trial team to ensure there are no interactions.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications, but you cannot have received strong or moderate CYP3A4 inhibitors or inducers within 7 days of enrollment. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
In earlier studies, SNDX-5613, also known as revumenib, showed promise in treating acute myeloid leukemia (AML), particularly in patients with specific genetic changes like NPM1 and MLL/KMT2A. Research has shown that about 33% of patients with these genetic changes experienced differentiation syndrome (DS), which can be managed with proper care.
Revumenib has also received FDA approval for treating AML with certain genetic mutations. This approval indicates that the drug's safety is considered acceptable for some patients, though it applies to a different stage of AML treatment.
The current trial is in its early stages. While previous studies provide some understanding of the drug's safety, researchers are still learning how well the combination of SNDX-5613 with chemotherapy is tolerated. Participants might experience some side effects, and the study aims to find a safe and effective dose.12345Why do researchers think this study treatment might be promising?
Unlike the standard chemotherapy treatment for acute myeloid leukemia, which typically involves drugs like daunorubicin and cytarabine, SNDX-5613 introduces a novel approach by targeting the Menin-MLL1 protein interaction. Most treatments focus on killing rapidly dividing cells, but SNDX-5613 specifically disrupts the growth of cancer cells by interfering with a critical process that these cells rely on. Researchers are excited about this treatment because it represents a more targeted attack on the disease, potentially leading to more effective outcomes with fewer side effects.
What evidence suggests that SNDX-5613 combined with chemotherapy could be effective for acute myeloid leukemia?
Research shows that SNDX-5613, also known as revumenib, holds promise for treating acute myeloid leukemia (AML) with specific genetic changes. In earlier studies, about 21% of patients achieved complete remission, where all signs of cancer disappeared, or experienced partial recovery of blood counts. Nearly one in five patients saw significant improvement in their cancer. In this trial, participants will receive SNDX-5613 combined with standard chemotherapy drugs daunorubicin and cytarabine. The treatment blocks signals that help cancer cells survive. These findings suggest that SNDX-5613 could enhance standard chemotherapy, potentially shrinking or controlling cancer for longer periods.12467
Who Is on the Research Team?
Alice Mims
Principal Investigator
Ohio State University Comprehensive Cancer Center LAO
Are You a Good Fit for This Trial?
This trial is for adults aged 18-75 with newly diagnosed acute myeloid leukemia that has specific gene changes (NPM1 or MLL/KMT2A) and are fit for intensive chemotherapy. Participants must have good organ function, an ECOG performance status of <=2, and if HIV-positive, they need undetectable viral load on effective therapy. Those with chronic hepatitis B or C must be on suppressive therapy or cured.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Patients receive revumenib orally every 12 hours on days 2-28, daunorubicin intravenously on days 1-3, and cytarabine by continuous IV infusion on days 1-7
Re-Induction
Patients receive revumenib orally every 12 hours on days 2-28, daunorubicin intravenously on days 1-2, and cytarabine by continuous IV infusion on days 1-5
Consolidation
Patients receive revumenib orally every 12 hours on days 2-28 and cytarabine by continuous IV infusion on days 1-3
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?
National Cancer Institute (NCI)
Lead Sponsor