Revumenib + Azacitidine + Venetoclax for Acute Myeloid Leukemia

(RAVEN Trial)

LH
Overseen ByLauren Higgins
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: UNC Lineberger Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination called RAVEN for individuals newly diagnosed with a specific type of acute myeloid leukemia (AML) known as KMT2A-translocated AML. The RAVEN combination includes Revumenib, Azacitidine, and Venetoclax. Researchers aim for this combination to improve outcomes and cause fewer side effects compared to current treatments. The trial consists of two phases: the first phase seeks to put the leukemia into remission, and the second phase continues treatment until certain conditions arise, such as the leukemia returning or receiving a stem cell transplant. Individuals with untreated KMT2A-translocated AML, who have not yet received any treatment, might be suitable candidates for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants, offering a chance to contribute to significant advancements in AML treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that combining revumenib, azacitidine, and venetoclax is generally safe for patients with certain types of acute myeloid leukemia (AML). Studies have found that this treatment can be administered safely and has shown promising results. Specifically, one study reported high rates of complete remission, indicating effective treatment for many patients' leukemia.

Additionally, revumenib was well-tolerated at various dose levels when used with azacitidine and venetoclax. Notably, researchers did not find a maximum tolerated dose, meaning the treatment did not cause unbearable side effects at the doses tested. This is reassuring for patients concerned about side effects. Overall, the combination has shown manageable side effects, offering hope for those seeking new treatments for AML.12345

Why are researchers excited about this trial's treatments for AML?

Unlike the standard treatments for acute myeloid leukemia (AML), which often include chemotherapy drugs like daunorubicin and cytarabine, this new combination therapy of Revumenib, Azacitidine, and Venetoclax targets the cancer in a unique way. Researchers are excited because Revumenib specifically targets the KMT2A-translocated type of AML, which is a genetic abnormality that makes the leukemia more aggressive and harder to treat. Venetoclax works by inhibiting proteins that help cancer cells survive, while Azacitidine modifies the DNA to stop cancer cell growth. This multi-pronged approach has the potential to be more effective against this challenging form of leukemia, offering hope for better outcomes.

What evidence suggests that the RAVEN treatment could be effective for acute myeloid leukemia?

Research has shown that the combination of revumenib, azacitidine, and venetoclax holds promise for treating acute myeloid leukemia (AML) with KMT2A translocation. In one study, 84% of patients achieved remission within the first 28-day treatment cycle, indicating that the treatment can rapidly reduce cancer cells. Patients generally tolerated the combination well, experiencing fewer severe side effects. The study reported an average survival time of 15.5 months, suggesting this treatment may extend life expectancy. Participants in this trial will receive this combination therapy to further evaluate its effectiveness and safety.12345

Who Is on the Research Team?

JZ

Joshua Zeidner, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for people newly diagnosed with a specific type of acute myeloid leukemia (AML) called KMT2A-rearranged AML. Participants should not have received prior treatment for this leukemia and must be healthy enough to undergo the study treatments.

Inclusion Criteria

Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information
Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee
I am between 18 and 65 years old.
See 1 more

Exclusion Criteria

Pregnant or breastfeeding (breast milk cannot be stored for future use while the mother is being treated on study)
I have AML that involves my blood or bone marrow, not just isolated myeloid sarcoma.
I do not have active leukemia in my brain or spinal cord.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Patients will receive treatment for up to 3 cycles, each lasting 28 days, to help the leukemia go into remission

12 weeks

Continuation

After remission and blood count recovery, patients will continue treatment until the leukemia returns, side effects become too severe, or another reason to stop treatment occurs

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Maintenance (optional)

Patients who receive an allogeneic stem cell transplant may join a separate part of the study to test revumenib as maintenance treatment after transplant

What Are the Treatments Tested in This Trial?

Interventions

  • Azacitidine
  • Revumenib
  • Venetoclax

Trial Overview

The study is testing a combination of three drugs—revumenib, azacitidine, and venetoclax (called RAVEN)—to see if they work better together in treating this type of AML. Treatment happens in cycles, with an option to continue after remission or use revumenib as maintenance after stem cell transplant.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials
377
Recruited
95,900+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40504618/

Azacitidine, Venetoclax, and Revumenib for Newly Diagnosed ...

The median time to first response was 28 days, and 84% of responders achieved remission within the first cycle. All 37 patients evaluated had ...

NCT06177067 | Study of Revumenib, Azacitidine, and ...

overall survival for patients treated remains the same at 21 days. being decreased from 21 days to 14 days, revumenib stays at 65 mg/m^2.

Syndax Announces Publication of Revumenib Data from ...

Revumenib was generally well-tolerated in combination with venetoclax/azacitidine in older, newly diagnosed mNPM1 and KMT2Ar AML patients –.

Azacitidine, Venetoclax, and Revumenib for Newly ...

The combination of azacitidine, venetoclax, and revumenib was able to be safely administered with high rates of CR and clinical activity.

AZACITIDINE, VENETOCLAX, AND REVUMENIB FOR ...

With a median follow-up of 6.9 months (mos) (range: 0.9-29.9), median overall survival (OS) was 15.5 mos (95% CI: 9.5-19.5) CRc was 12 mos.