Pevonedistat + Belinostat for Acute Myeloid Leukemia or Myelodysplastic Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the side effects and optimal dose of two chemotherapy drugs, pevonedistat and belinostat, for individuals with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that have recurred or are unresponsive to treatment. These drugs aim to stop cancer cells from growing, dividing, or spreading. The trial may suit those diagnosed with AML or higher-risk MDS who have not responded to at least one previous treatment. 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 potentially groundbreaking therapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that ongoing treatment with certain enzyme inducers and strong inhibitors of UGT1A1 is not allowed. It's important to discuss your current medications with the trial team to understand any potential interactions.
Is there any evidence suggesting that pevonedistat and belinostat are likely to be safe for humans?
Research shows that the combination of pevonedistat and belinostat is generally safe for adults with relapsed or hard-to-treat acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). Studies have found that most people tolerate this treatment well, with side effects mainly affecting blood counts. While the treatment has shown some promise in fighting cancer, monitoring these blood-related side effects is important.
Prospective participants in a clinical trial with this treatment can find reassurance in the fact that previous patients have managed the side effects. However, as with any treatment, discussing potential risks with a doctor is crucial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of pevonedistat and belinostat for treating acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) because it introduces a novel approach compared to standard treatments. Unlike traditional chemotherapies, which often target rapidly dividing cells indiscriminately, pevonedistat works by inhibiting a specific enzyme pathway crucial for cancer cell survival, potentially leading to more targeted cancer cell death. Belinostat, on the other hand, is a histone deacetylase inhibitor that can modify the expression of genes involved in cancer growth. Together, they offer a dual mechanism that might improve outcomes by attacking cancer cells in multiple ways, creating a promising potential for more effective and less toxic treatment options.
What evidence suggests that pevonedistat and belinostat might be effective for acute myeloid leukemia or myelodysplastic syndrome?
Research has shown that the combination of pevonedistat and belinostat, which trial participants will receive, may benefit patients with relapsed or hard-to-treat acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Studies have found this treatment to be generally safe and capable of positively affecting the disease. In earlier research, some patients' conditions remained stable, meaning their disease did not worsen over time. This treatment aims to stop cancer cells from growing and dividing, helping to manage the disease. While the benefits are modest, the treatment's safety suggests it could be an option for those who haven't responded to other treatments.12367
Who Is on the Research Team?
Keri R Maher
Principal Investigator
University Health Network Princess Margaret Cancer Center LAO
Are You a Good Fit for This Trial?
This trial is for adults with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), who have tried at least one treatment before. They should not have a history of certain diseases, like AIDS or active hepatitis, and must be generally healthy with an ECOG performance status of <=2. Participants need to use effective contraception and understand the study's consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Belinostat
- Pevonedistat
Belinostat is already approved in United States for the following indications:
- Peripheral T-cell lymphoma (PTCL)
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor