Pevonedistat + Belinostat for Acute Myeloid Leukemia or Myelodysplastic Syndrome
Trial Summary
What is the purpose of this trial?
This phase I trial studies side effects and best dose of pevonedistat and belinostat in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has come back (relapsed) or does not respond to treatment (refractory). Chemotherapy drugs, such as pevonedistat and belinostat, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
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.
What data supports the effectiveness of the drug combination Pevonedistat and Belinostat for treating Acute Myeloid Leukemia or Myelodysplastic Syndrome?
Research shows that the combination of Pevonedistat and Belinostat can effectively kill leukemia cells by disrupting their DNA repair processes, leading to cell death. This combination has shown promise in reducing tumor burden and improving survival in animal models, suggesting potential benefits for patients with these conditions.12345
What is known about the safety of Pevonedistat and Belinostat in humans?
What makes the drug combination of Pevonedistat and Belinostat unique for treating acute myeloid leukemia or myelodysplastic syndrome?
The combination of Pevonedistat and Belinostat is unique because Pevonedistat inhibits a key enzyme involved in protein degradation, which affects cell growth and survival, while Belinostat is an HDAC inhibitor that affects gene expression and promotes cancer cell death. This dual approach targets different mechanisms in cancer cells, potentially offering a novel treatment option for these conditions.13678
Research Team
Keri R Maher
Principal Investigator
University Health Network Princess Margaret Cancer Center LAO
Eligibility Criteria
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
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
Treatment Details
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