Revumenib + Chemotherapy for Childhood Leukemia
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.12345
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1a Treatment
Determine the highest tolerable dose of revumenib in combination with cytarabine, daunorubicin, and gemtuzumab ozogamicin
Phase 1b Treatment
Assess if the dose of revumenib found in Phase 1a can help control the disease
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cytarabine
- Daunorubicin
- Revumenib
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor