Study on CPX-351 and Enasidenib for Treating Relapsed Acute Myeloid Leukemia (AML)

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40

ClinicalTrials ID:NCT03825796

This clinical trial is testing a combination of two drugs, CPX-351 and enasidenib, to see if they work better together in treating patients with relapsed acute myeloid leukemia (AML) that has a specific IDH2 mutation.

Patient Parameters

Parameter	Options

Program Overview

The purpose of this study is to find out if using CPX-351 and enasidenib together can more effectively treat patients with acute myeloid leukemia (AML) that has come back after treatment and has a specific genetic mutation called IDH2. CPX-351 is a type of chemotherapy that works by stopping cancer cells from growing, while enasidenib blocks certain enzymes needed for cancer cell growth. Researchers believe that combining these two drugs might be more effective than using either one alone.

Description

Primary Goal:

To find out how many patients achieve remission (where cancer is no longer detectable) using the combination of CPX-351 and enasidenib in adults with relapsed AML that has a specific IDH2 mutation.

Secondary Goals:

To check for any severe blood-related side effects by day 60 of treatment.
To see if enasidenib can help patients who have stable disease after initial treatment with CPX-351.
To measure how quickly normal blood cell production returns after treatment.
To evaluate survival rates at 30 and 60 days.
To see if this treatment can help patients prepare for a stem cell transplant.

Exploratory Goals:

To identify other genetic mutations present with the IDH2 mutation in patients who achieve remission.
To measure the depth of response to treatment using advanced genetic testing.
To assess any potential heart-related side effects of CPX-351.

Treatment Plan:

Induction Phase: Patients receive CPX-351 through an IV on specific days and take enasidenib by mouth for up to 60 days, unless the disease progresses or side effects are too severe. If needed, a second round of treatment may be given.
Consolidation Phase: Patients who achieve remission may proceed to a stem cell transplant or receive up to 4 cycles of additional treatment. Younger patients receive a higher dose of cytarabine, while older patients receive a lower dose. Enasidenib is continued during this phase.
Maintenance Phase: Patients with stable disease at day 60 continue taking enasidenib daily, with regular follow-up visits every 3 months.

Eligibility Criteria

Inclusion Criteria

Have AML with at least 5% cancer cells in the bone marrow after previous remission.
Have AML with the IDH2 gene mutation.
Previously treated with an IDH2 inhibitor is allowed.
Had at least 3 months of remission before relapse.
Relapsed after a stem cell transplant is allowed.
Can have had one cycle of a specific type of chemotherapy at relapse.
Good overall health with an ECOG score of 0-2.
Meet specific blood and organ function criteria.
Agree to use effective birth control during and after the study.

Exclusion Criteria

Have a specific FLT3 mutation requiring targeted treatment.
Have acute promyelocytic leukemia.
Cannot swallow pills or have digestive issues.
Have another active cancer limiting life expectancy to less than 2 years.
Have severe heart conditions or low heart function.
Have a history of certain heart procedures requiring ongoing medication.
Have a prolonged QT interval on an ECG.
Have a history of certain genetic disorders.
Allergic to study drugs.
Have active infections or recent severe infections.
Have received high doses of certain chemotherapy drugs.
Are pregnant or breastfeeding.

Locations

FACILITY	ZIP	CITY	STATE
UCLA / Jonsson Comprehensive Cancer Center	90095	Los Angeles	California
University of California Davis Comprehensive Cancer Center	95817	Sacramento	California
University of California San Diego	92103	San Diego	California

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.