Pevonedistat + Decitabine for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

Overseen by Guido Marcucci

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

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.

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

You are 60 years or older and your disease has come back or is not responding to treatment.

If you have cancer cells that have spread outside of your bone marrow, you may still be eligible for the study if you meet other criteria.

You have other medical conditions, but they are not expected to shorten your life expectancy within the next six months.

Exclusion Criteria

You do not have any other active cancer except for certain types that have been cured or treated a long time ago.

You have a serious medical or mental health condition that could affect your ability to participate in the study.

You have not taken any experimental medications within the 2 weeks before starting the study.

Participant Groups

The study is testing the combination of two drugs: pevonedistat and decitabine, to determine their safety and optimal dosages in treating high-risk AML. The goal is to see if these drugs can halt cancer growth by inhibiting enzymes necessary for cell proliferation.

Group I: Treatment (pevonedistat, decitabine) Experimental Treatment 4 Interventions

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.

Decitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Dacogen for:

• Acute myeloid leukemia
• Myelodysplastic syndromes

🇺🇸 Approved in United States as Dacogen for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

🇨🇦 Approved in Canada as Dacogen for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

🇯🇵 Approved in Japan as Dacogen for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

City of Hope Medical Center Duarte, CA

Who Is Running the Clinical Trial?

City of Hope Medical Center Lead Sponsor

National Cancer Institute (NCI) Collaborator

References