Pevonedistat + Decitabine for Acute Myeloid Leukemia
Trial Summary
What is the purpose of this trial?
This phase I trial studies the side effects and best dose of pevonedistat when given together with decitabine in treating patients with high risk acute myeloid leukemia. Pevonedistat and decitabine may stop the growth of cancer cells by blocking some of the enzymes need for cell growth.
Research Team
Guido Marcucci
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
This trial is for adults aged 60 or older with high-risk acute myeloid leukemia (AML), either newly diagnosed, untreated and not candidates for standard chemotherapy, or those with relapsed/refractory disease. It includes younger AML patients unfit for stem cell transplant. Participants must have a life expectancy over 6 months, be able to perform daily activities (ECOG <=2), and use effective contraception if of childbearing potential.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5 and decitabine IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unexpected toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Decitabine
- Pevonedistat
Decitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Myelodysplastic syndromes
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Acute myeloid leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator