What is CPX-351 studying for acute myeloid leukemia (AML)?

CPX-351 is being studied to see how it compares with standard chemotherapy in treating patients with newly diagnosed AML who have certain genetic risk factors. The study aims to find out if CPX-351 can improve deep remission rates using detailed blood and bone marrow tests. The trial is sponsored by the Centre Hospitalier Universitaire de Nice to improve treatment options for AML patients.

Who may be eligible for this acute myeloid leukemia clinical trial?

Adults aged 50 years or older with newly diagnosed de novo AML may be eligible. Participants must not have certain gene mutations or prior treatment for AML, and need adequate organ function and performance status. Both males and females can join if they meet the requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this acute myeloid leukemia clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any transportation or accommodation needs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID05260528

Phase II Study Comparing CPX-351 and Intensive Chemotherapy in Adults With New Diagnosed de Novo Acute Myeloid Leukemia Having Intermediate or Adverse Risk Based on Genetics

Led by Centre Hospitalier Universitaire de Nice · Updated on 2026-03-27

248

Participants Needed

Research Sites

78 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating treatments for acute myeloid leukemia AML, a blood cancer where myeloid cells grow uncontrollably. This study focuses on patients newly diagnosed with de novo AML who have intermediate or adverse genetic risk. It aims to compare the effects of a new drug combination, CPX-351, against standard intensive chemotherapy, especially in patients with certain genetic mutations linked to worse outcomes with current treatments. Participants will be randomly assigned to receive either CPX-351 or the standard chemotherapy regimen known as 73, which includes cytarabine and idarubicin. CPX-351 is given intravenously on specific days for induction and consolidation phases, while the standard chemotherapy follows a different schedule. The study will monitor how well these treatments reduce leukemia cells, using detailed genetic and flow cytometry tests, and explore biomarkers like P-gp activity. During the trial, participants will undergo bone marrow and blood tests to measure minimal residual disease MRD after treatment. Researchers will track remission rates, survival outcomes, side effects, quality of life, and changes in genetic markers for up to several years. Patients must be able to attend regular visits and blood sampling sessions throughout the study to support these evaluations.

CONDITIONS

Brief Title

CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosis of de novo acute myeloid leukemia (AML)
No myelodysplastic-related cytogenetic lesions
No specific genetic abnormalities including t(15;17), t(8;21), inv(16), or t(16;16)
No mutation in NPM1 gene
No FLT3 mutated AML (including ITD or TKD types)
No prior AML treatment except short hydroxyurea for high white blood cell count or tumor symptoms
Age 50 years or older
Performance status of 2 or less on the ECOG scale
Adequate organ function as defined in the study protocol
Female participants must have a negative pregnancy test before treatment and not be breastfeeding
Female participants must be post-menopausal, surgically sterilized, or use two effective contraception methods during the study
Male participants must use effective contraception during the study and for 3 months after last treatment
Willingness and ability to attend study visits and blood sampling
Ability to understand and sign informed consent
Registered with French Social Security

You will not qualify if you...

Prior history of myelodysplastic syndrome (MDS), myeloproliferative neoplasm (MPN), or related conditions
Previous radiation therapy or chemotherapy for solid tumors or lymphoma (except local prostate radiotherapy)
Active and uncontrolled infection
Uncontrolled illnesses or conditions that may affect study compliance, including heart failure, unstable angina, arrhythmia, pancreatitis, or psychiatric/social issues
Participation in another investigational study within 30 days before dosing
Known HIV infection or related malignancy
Active hepatitis B or C infection
Allergy to CPX-351, idarubicin, or cytarabine
Currently active second cancer except certain skin or cervical cancers, unless disease-free for over a year or low relapse risk
Clinical evidence of central nervous system leukemia
Cardiac ejection fraction below 50% or abnormal heart scan results
Pregnancy or breastfeeding during the study period

Research Team

valerie Foussat

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Phase II Study Comparing CPX-351 and Intensive Chemotherapy in Adults With New Diagnosed de Novo Acute Myeloid Leukemia Having Intermediate or Adverse Risk Based on Genetics

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria