CPX-351 + Enasidenib for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Caspian Oliai, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Jonsson Comprehensive Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial evaluates how well CPX-351 and enasidenib work in treating patients with acute myeloid leukemia characterized by IHD2 mutation. Drugs used in chemotherapy, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving CPX-351 and enasidenib may work better in treating patients with acute myeloid leukemia, compared to giving only one of these therapies alone.

Eligibility Criteria

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.

Inclusion Criteria

My bilirubin levels are below 2.0 mg/dL, or high due to Gilbert's disease.

Alkaline phosphatase < 3 times the upper limit of normal, unless considered due to leukemic involvement

My AML is caused by an IDH2 gene mutation.

Exclusion Criteria

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

Left ventricular ejection fraction < 40%

Baseline QT corrected interval based on Fridericia's formula (QTcF) interval > 450 ms

Treatment Details

Interventions

• Enasidenib Mesylate (Anti-metabolites)
• Liposome-encapsulated Daunorubicin-Cytarabine (Anti-tumor antibiotic)

Trial Overview 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.

Participant Groups

Group I: Treatment (CPX-351, enasidenib mesylate) Experimental Treatment 2 Interventions

See detailed description

Enasidenib Mesylate is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Idhifa for:

• Relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH2) mutation

🇪🇺 Approved in European Union as Idhifa for:

• Acute myeloid leukemia with an IDH2 mutation

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California San Francisco San Francisco, CA

University of California San Diego San Diego, CA

UCLA / Jonsson Comprehensive Cancer Center Los Angeles, CA

University of California Davis Comprehensive Cancer Center Sacramento, CA

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center Lead Sponsor

Jazz Pharmaceuticals Industry Sponsor

References