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Anti-metabolites

CPX-351 + Enasidenib for Acute Myeloid Leukemia

Phase 2

Waitlist Available

Led By Caspian Oliai, MD

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

AML characterized by the IDH2 gene mutation, without requirement for a particular allelic frequency

Relapses after allogeneic HSCT are included with a minimum of 3 from the date of allogeneic HSCT

Must not have

History of coronary stent placement that require mandatory continuation of dual-antiplatelet therapy

Acute promyelocytic leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Summary

This trial evaluates how two drugs, CPX-351 and enasidenib, work together to treat a type of leukemia. Together, they may be more effective than using just one.

Who is the study for?

This trial is for adults with acute myeloid leukemia (AML) that has returned after treatment. Participants must have an IDH2 gene mutation, be in relatively good health based on specific blood tests and organ function, and not have had certain other treatments or conditions that could interfere with the study.Check my eligibility

What is being tested?

The trial is testing a combination of two drugs: CPX-351 (a chemotherapy drug) and enasidenib mesylate (which blocks enzymes cancer cells need to grow). The goal is to see if using both drugs together works better than using them separately for treating AML with an IDH2 mutation.See study design

What are the potential side effects?

Potential side effects include typical chemotherapy-related issues like fatigue, nausea, hair loss, increased risk of infection due to low blood cell counts, liver problems indicated by elevated enzyme levels, as well as possible allergic reactions to the medications.

Eligibility Criteria

Inclusion Criteria

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

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My AML is caused by an IDH2 gene mutation.

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I had a stem cell transplant from a donor and it's been at least 3 months since.

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I am able to care for myself and perform daily activities.

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My kidney function is within the required range.

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I have been treated with an IDH2 inhibitor before.

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My AML has returned, shown by more than 5% bone marrow blasts after initial remission.

Exclusion Criteria

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

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I must continue taking two blood thinner medications due to a heart stent.

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I have been diagnosed with acute promyelocytic leukemia.

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My heart condition severely limits my physical activity.

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I currently have an active fungal infection.

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I have a history of Wilson's disease or similar conditions.

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I have received more than 368 mg/m^2 of anthracycline-based chemotherapy.

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I cannot swallow pills or have a disease that affects how my body absorbs food.

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My doctor expects me to live more than two years despite my cancer.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete remission (CR)/CR with incomplete hematologic recovery (CRi) after induction therapy

Secondary outcome measures

Overall survival

Proportion of patients who achieve CR/CRi during maintenance therapy

Proportion of patients who achieve CR/complete remission with partial hematologic recovery (CRp) after induction therapy

+3 more

Other outcome measures

Proportion of abnormal electrocardiogram (ECG) findings (new T-wave inversions or new ST segment abnormalities)

Proportion of abnormal troponin levels without concurrent elevated creatinine

Proportion of echocardiogram findings with left ventricular ejection fraction reduction by >= 25%

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (CPX-351, enasidenib mesylate)Experimental Treatment2 Interventions

See detailed description

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

FDA approved

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

365 Previous Clinical Trials

27,946 Total Patients Enrolled

Jazz PharmaceuticalsIndustry Sponsor

249 Previous Clinical Trials

34,901 Total Patients Enrolled

Caspian Oliai, MDPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

3 Previous Clinical Trials

37 Total Patients Enrolled

~0 spots leftby Sep 2024

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