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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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

CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics (NCT05260528) is a Phase 2 interventional studying Acute Myeloid Leukemia, sponsored by Centre Hospitalier Universitaire de Nice. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The trial is a randomized, open-label phase II study comparing CPX-351 vs conventional intensivechemotherapy in patients with newly diagnosed de novo AML and intermediate- or adverse-risk genetics

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Acute Myeloid Leukemia and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 248 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Acute Myeloid Leukemia subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 your organs (liver, kidneys, etc.) are working well enough based on blood tests 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 willing to sign a consent form form indicating the investigational nature of the study. 15. Patient registered to the French Social Security. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Cytarabine and Idarubicin

Induction 1: Cytarabine 200 mg/m2 i.v. (continuously) d1-7 + Idarubicin 12mg/m2 d1, 2, 3 i.v (60 min) Induction 2: Cytarabine 1500 mg/m2 i.v. q12h d1-3 Consolidation: Cytarabine 1500 mg/m2 i.v. q12h d1-3

DRUG

CPX-315

Induction 1:CPX-351 44 mg/m2 daunorubicin / 100 mg/m2 cytarabine i.v. (90 min) d1,3,5 Induction 2: CPX-351 44 mg/m2 daunorubicin / 100 mg/m2 cytarabine i.v. (90 min) d1,3 Consolidation therapy:CPX-351 29 mg/m2 daunorubicin / 65 mg/m2 cytarabine i.v. (90 min) d1,3

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

CHU Amiens Picardie site Sud
Amiens, France
CHU d'Angers
Angers, France
CH Avignon
Avignon, France
CHRU Jean Minjoz
Besançon, France
Centre Hospitalier de Béziers
Béziers, France
Hôpital Avicenne APHP
Bobigny, France
Institut d'hématologie de Basse Normandie (IHBN)
Caen, France
Hôpital d'Instruction des Armée (HIA)
Clamart, France
CHU Estaing
Clermont-Ferrand, France
Centre Hospitalier Sud Francilien (CHSF)
Corbeil-Essonnes, France
CHU Henri Mondor
Créteil, France
Centre Hospitalier de Versailles, Site André Mignot
Le Chesnay, France
Hôpital Claude HURIEZ, CHU Lille
Lille, France
CHU de Limoges
Limoges, France
Hoptial de la Conception APHM
Marseille, France
Institut Paoli Calmettes
Marseille, France
CHR Metz-Thionville Site Mercy
Metz, France
Groupe hospitalier de la région de Mulhouse et Sud-Alsace, Hôpital Emile Muller
Mulhouse, France
CHU de Nantes
Nantes, France
Centre Antoine Lacassagne
Nice, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05260528), the sponsor (Centre Hospitalier Universitaire de Nice), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05260528 clinical trial studying?

The trial is a randomized, open-label phase II study comparing CPX-351 vs conventional intensivechemotherapy in patients with newly diagnosed de novo AML and intermediate- or adverse-risk genetics The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05260528?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05260528?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05260528. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05260528. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.