30 Participants Needed

Pevonedistat + Decitabine for Acute Myeloid Leukemia

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: City of Hope Medical Center
Must be taking: Hydroxyurea
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

GM

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

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.
See 26 more

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.
See 21 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months
Monthly for 1 year, bi-monthly for another year

Treatment Details

Interventions

  • Decitabine
  • Pevonedistat
Trial Overview 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (pevonedistat, decitabine)Experimental Treatment4 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:

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Approved in European Union as Dacogen for:
  • Acute myeloid leukemia
  • Myelodysplastic syndromes
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Dacogen for:
  • Myelodysplastic syndromes
  • Acute myeloid leukemia
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Dacogen for:
  • Myelodysplastic syndromes
  • Acute myeloid leukemia
๐Ÿ‡ฏ๐Ÿ‡ต
Approved in Japan as Dacogen for:
  • Myelodysplastic syndromes
  • Acute myeloid leukemia

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
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