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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
Serum total bilirubin < 2.0 mg/dL, unless considered due to Gilbert's disease or leukemic involvement
AML characterized by the IDH2 gene mutation, without requirement for a particular allelic frequency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study 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 bilirubin levels are below 2.0 mg/dL, or high due to Gilbert's disease.
Select...
My AML is caused by an IDH2 gene mutation.
Select...
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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I agree to use effective birth control or abstain from sex during and 4 months after the study.
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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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I've had only one round of a specific drug treatment for my cancer and stopped it at least two weeks ago.
Select...
My AML has returned, shown by more than 5% bone marrow blasts after initial remission.
Select...
My cancer was in complete remission for at least 3 months before it came back.

Timeline

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

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,073 Total Patients Enrolled
Jazz PharmaceuticalsIndustry Sponsor
248 Previous Clinical Trials
34,357 Total Patients Enrolled
Caspian Oliai, MDPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
3 Previous Clinical Trials
37 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what medical ailments is CPX-351, enasidenib mesylate prescribed?

"CPX-351, also known as enasidenib mesylate, is frequently prescribed to tackle infections. It has been demonstrated to be clinically effective for multiple myelocytic leukemias, meningeal leukemia and acute ureteric calculi."

Answered by AI

Are there multiple sites that oversee this research?

"This trial is being conducted across 4 sites: University of California San Francisco (San Francisco), UCLA / Jonsson Comprehensive Cancer Center (Los Angeles), and University of California San Diego (San Diego) as well as four other facilities."

Answered by AI

Have CPX-351 and enasidenib mesylate been trialed in other scientific experiments?

"Presently, there is a wealth of clinical trials focusing on Treatment (CPX-351, enasidenib mesylate), with 66 of them in the late stages phase 3. Out of the 13525 locations operating trials for this medication, some are located near Bronx, New york."

Answered by AI

Can applicants still join this experiment?

"According to clinicaltrials.gov, recruitment for this trial has already been completed. Initially posted on April 12th 2019 and last updated September 26th 2023, the study is no longer recruiting patients; however there are 1,708 other active trials seeking volunteers at present."

Answered by AI

To what extent can CPX-351, enasidenib mesylate be detrimental to patients?

"A score of 2 was assigned to Treatment (CPX-351, enasidenib mesylate) due to its Phase 2 nature; some safety data exists but efficacy is yet unconfirmed."

Answered by AI

What is the scope of participation for this clinical exploration?

"This research study is no longer actively recruiting participants. It was initially listed on April 12th 2019 and the latest update occurred September 26th 2023. If you are looking for other medical studies, there are presently 1434 trials searching for those with acute myeloid leukemia as well as 274 that have open enrollment regarding treatment through CPX-351 or enasidenib mesylate."

Answered by AI
~0 spots leftby Sep 2024