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Anti-metabolites

Pevonedistat + Chemotherapy for Acute Myeloid Leukemia

Phase 1 & 2

Waitlist Available

Led By Kevin Kelly, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0-2

Patients with previously untreated AML (except acute promyelocytic leukemia [APL]) who meet specific criteria

Must not have

Known hepatic cirrhosis or severe pre-existing hepatic impairment

Patients who refuse to potentially receive blood products and/or have a hypersensitivity to blood products

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is testing pevonedistat, a drug that may stop the growth of cancer cells, in combination with cytarabine and idarubicin, drugs that work in different ways to stop the growth of cancer cells.

Who is the study for?

This trial is for adults with acute myeloid leukemia (AML) who are fit for chemotherapy, have certain genetic features or a history of myelodysplastic syndrome, and haven't had AML treatment. Participants must be able to perform daily activities with minimal assistance (ECOG 0-2), have adequate organ function, agree to use contraception if they can have children, and not expect other serious health issues within the next 3 months.

What is being tested?

The study tests pevonedistat combined with cytarabine and idarubicin in treating AML. Pevonedistat may block enzymes that cancer cells need to grow. Cytarabine and idarubicin are chemotherapy drugs that kill or stop cancer cells from dividing. The trial aims to find the best dose of pevonedistat and see how well this combination works.

What are the potential side effects?

Possible side effects include reactions at the infusion site, fatigue, nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems. Heart complications might occur due to pre-existing conditions or drug interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and perform daily activities.

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I have AML (not APL) and haven't received treatment for it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe liver problems or cirrhosis.

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I refuse blood products or am allergic to them.

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I am not pregnant, breastfeeding, or lactating.

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I haven't had or been treated for another cancer within the last 2 years.

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I do not have a bleeding disorder that is currently uncontrolled.

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I am HIV positive.

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I have received chemotherapy for acute myeloid leukemia.

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My cancer has spread to my brain or spinal cord.

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I have a known heart or lung condition.

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I have a serious lung condition like COPD, lung scarring, or fibrosis.

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I do not have any severe or uncontrolled infections.

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I haven't had major surgery in the last 14 days and don't plan any during the study.

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I do not have a life-threatening illness unrelated to my cancer.

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I am allergic to cytarabine or anthracyclines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite complete response rate

Incidence of adverse events (Phase Ib)

Secondary study objectives

Relapse-free survival (RFS)

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (idarubicin, cytarabine, pevonedistat)Experimental Treatment5 Interventions

INDUCTION: Patients receive idarubicin IV over 10-15 minutes on days 1-3, cytarabine IV over 1-3 hours on days 1-7, and pevonedistat IV over 60 minutes on days 1, 3, and 5. Patients with gross residual disease on day 14 bone marrow may receive a second course of induction chemotherapy. CONSOLIDATION: Patients who achieve CR and will not undergo bone marrow transplant receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28-35 days for 4 courses in the absence of disease progression or unaccepted toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

FDA approved

Pevonedistat

Not yet FDA approved

Idarubicin

FDA approved

0 / 16Eligibility criteria met