Revumenib + Chemotherapy for Childhood Leukemia

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Chemotherapeutic agents

Disqualifiers: Uncontrolled conditions, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments for children with certain types of leukemia, a blood cancer. Researchers aim to determine the safest dose of a new drug, revumenib, when combined with other chemotherapy drugs, cytarabine and daunorubicin. They hope this combination will better control the disease. Children and young adults with acute leukemia, especially if it has returned or not responded to other treatments, might be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug combination.

Do I have to stop taking my current medications for the trial?

The trial requires a break of at least 14 days from your previous treatment before starting the new treatment, unless it's shorter based on the previous medication's half-life. Some medications like hydroxyurea and certain CNS therapies are allowed during the study, but other chemotherapeutic or anti-leukemic agents are not permitted.

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

Research has shown that revumenib, when combined with treatments like venetoclax and azacitidine, is generally well-tolerated. Earlier studies did not identify a maximum safe dose for this combination, suggesting revumenib might be safe at various doses. However, this trial remains in an early stage, with the primary goal of determining the right dose and ensuring safety. The treatment is being tested alongside cytarabine, daunorubicin, and gemtuzumab ozogamicin, common drugs for leukemia. Although these drugs are familiar, their use with revumenib is new, and researchers are working to ensure patient safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for leukemia?

Unlike the standard treatments for childhood leukemia, which typically involve chemotherapy agents like cytarabine and daunorubicin, Revumenib introduces a novel approach. Revumenib is unique because it targets specific proteins within cancer cells, potentially offering a more precise attack on leukemia cells. Researchers are excited about Revumenib because it could enhance the effectiveness of existing chemotherapies, leading to better outcomes and fewer side effects for young patients. This targeted action distinguishes it from traditional chemotherapy, which often affects both healthy and cancerous cells.

What evidence suggests that this trial's treatments could be effective for childhood leukemia?

This trial studies revumenib in combination with the chemotherapy drugs cytarabine and daunorubicin to treat acute leukemia. Research has shown that revumenib targets specific proteins in cancer cells, potentially stopping their growth. Cytarabine and daunorubicin are well-known chemotherapy drugs that kill cancer cells or prevent them from dividing. Combining these treatments aims to enhance effectiveness by attacking leukemia cells in different ways. While early results appear promising, further research is needed to confirm their benefits in controlling the disease. Participants in this trial will join either the dose escalation or dose expansion arms, both involving the combination of revumenib with cytarabine and daunorubicin.

Who Is on the Research Team?

Branko Cuglievan, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for pediatric patients with acute leukemia, either newly diagnosed or those who have relapsed after previous treatments. Specific eligibility criteria are not provided, but typically include factors like age range, disease stage, and overall health status.

Inclusion Criteria

WBC must be below 25,000/µL at enrollment

Baseline ejection fraction > 50%

Potassium should be maintained at ≥ 4.0 mEq/L and magnesium at > 2.0 mg/dL

Exclusion Criteria

Pregnant or breast-feeding females

QTc interval prolongation

History of conditions that may confound study results

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a Treatment

Determine the highest tolerable dose of revumenib in combination with cytarabine, daunorubicin, and gemtuzumab ozogamicin

8-12 weeks

Inpatient treatment

Phase 1b Treatment

Assess if the dose of revumenib found in Phase 1a can help control the disease

8-12 weeks

Inpatient treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cytarabine
• Daunorubicin
• Revumenib

Trial Overview

The study aims to determine the safest high dose of Revumenib when used with Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Phase Ia. In Phase Ib, it will assess if this combination can effectively manage childhood leukemia at that dose.

How Is the Trial Designed?

Group I: Dose Expansion of Revumenib in combination with cytrabine and Daunorubicin and GO Experimental Treatment 3 Interventions

Treatment will be administered on an inpatient basis

Group II: Dose Escalation of Revumenib in combination with cytrabine and Daunorubicin and GO Experimental Treatment 3 Interventions

Treatment will be administered on an inpatient basis

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11060303/

Revumenib (SNDX-5613): a promising menin inhibitor for ...

Revumenib, like many targeted therapies, carries the risk of developing resistance over time, which could reduce its efficacy in the long run.

2.

uchicagomedicine.org

uchicagomedicine.org/find-a-clinical-trial/clinical-trial/cirb240415

CLINICAL TRIAL / NCT05886049

This phase Ib trial tests the safety, side effects, and best dose of SNDX-5613 when given in combination with the standard chemotherapy treatment (daunorubicin ...

3.

ir.syndax.com

ir.syndax.com/news-releases/news-release-details/syndax-announces-publication-revumenib-data-beat-aml-trial

Syndax Announces Publication of Revumenib Data from the ...

Revumenib was generally well tolerated at both dose levels in combination with venetoclax and azacitidine without a maximal tolerated dose identified.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07052994

NCT07052994 | A Phase Ia/Ib Trial of Revumenib ...

The goal of Phase 1a of this clinical research study is to find the highest tolerable dose of revumenib that can be given in combination ...

5.

withpower.com

withpower.com/trial/phase-1-pediatric-acute-leukemia-11-2025-08649

Revumenib + Chemotherapy for Childhood Leukemia

Trial Overview The study aims to determine the safest high dose of Revumenib when used with Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Phase Ia ...