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Comparing CPX-351 to Intensive Chemotherapy for Acute Myeloid Leukemia

An ALFA 2101 Multicenter Randomized Phase II Study: CPX-351 Versus Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics

Phase 2 Interventional Centre Hospitalier Universitaire de Nice · NCT05260528

This study is testing if a new treatment called CPX-351 can help older patients with a tough form of leukemia do better than traditional chemotherapy.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment248 (estimated)
Ages18 Years and up
SexAll
SponsorCentre Hospitalier Universitaire de Nice Academic / other
Drugs / interventionschemotherapy, radiation
Locations35 sites (Amiens and 34 other locations)
Trial IDNCT05260528 on ClinicalTrials.gov

What this trial studies

This phase II trial is a randomized, open-label study that compares the efficacy of CPX-351 against conventional intensive chemotherapy in patients with newly diagnosed de novo acute myeloid leukemia (AML) who have intermediate or adverse-risk genetic profiles. The study focuses on patients aged 50 and older, particularly those with specific secondary-type mutations that are associated with poorer outcomes when treated with standard chemotherapy. The primary goal is to evaluate the rate of minimal residual disease (MRD) negative remissions achieved with CPX-351 as both induction and consolidation therapy. The trial aims to provide new therapeutic options for this high-risk patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 50 years and older with newly diagnosed de novo AML and specific intermediate or adverse-risk genetic mutations.

Not a fit: Patients with certain genetic mutations such as FLT3 or NPM1, or those with prior treatment for AML, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a more effective treatment option for patients with high-risk acute myeloid leukemia, potentially improving remission rates.

How similar studies have performed: Other studies have indicated that targeted therapies for specific genetic mutations in AML can lead to improved outcomes, suggesting that this approach may be promising.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. De novo AML
2. No MRC-defining cytogenetic lesion
3. No t(15;17), t(8;21), inv(16) or t(16;16)
4. No NPM1 gene mutation
5. No FLT3 mutated AML (FLT3 ITD or TKD)
6. Not previously treated except for short course hydroxyurea in patients presenting with high WBC count and/or tumor symptoms,
7. Age ≥ 50 years,
8. Performance status ≤ 2 (ECOG grading),
9. Patient must have adequate organ function as indicated detailed with laboratory values in the section IV of the protocol
10. Female patient of childbearing potential with a negative serum pregnancy test (β-hCG) within 72 hours prior to receiving the first dose of CPX-351 or 7+3. Female patient who is not actively breastfeeding at the time of study entry.
11. Female patient is either post-menopausal, free from menses for \> 2 years, surgically sterilized or willing to use 2 adequate barrier methods of contraception to prevent pregnancy, or agrees to not become pregnant throughout the study, starting with study screening
12. Male patient agrees to use an adequate method of contraception for the duration of the study. Men should be advised not to father a child while receiving CPX-351 or 7+3 and for 3 months after the last dose of study treatment .
13. Patient is available for periodic blood sampling, study related assessments, and appropriate clinical management at the treating institution for the duration of the study.
14. Patient has the ability to understand and willingness to sign an informed consent form indicating the investigational nature of the study.
15. Patient registered to the French Social Security.

Exclusion Criteria:

1. Prior history of documented MDS, MPN or MDS/MPN, tAML
2. Prior history of radiation therapy or chemotherapy for a solid tumor or lymphoma (exceptions to be considered: local radiotherapy for prostate cancer)
3. Patient has active and uncontrolled infection.
4. Patient has uncontrolled intercurrent illness or circumstances that could limit compliance with the study, including but not limited to the following: symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, pancreatitis, or psychiatric or social conditions that may interfere with patient compliance.
5. Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of initial dosing with study drug.
6. Patient has known human immunodeficiency virus (HIV) infection or HIV-related malignancy.
7. Patient has clinically active hepatitis B or hepatitis C infection.
8. Patient has a known allergy or hypersensitivity to any component of CPX-351, idarubicin or cytarabine.
9. Patient with a "currently active" second malignancy, other than nonmelanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled. Patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for \>1 year or are considered by their physician to be at less than 30% risk of relapse.
10. Patients with clinical evidence of CNS leukemia.
11. Cardiac ejection fraction \<50% or considered as abnormal by echocardiography or multi-gated acquisition (MUGA) scan.
12. Patient is pregnant or breastfeeding within the projected duration of the study.

Where this trial is running

Amiens and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Myeloid LeukemiaCPX-351
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.