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Acute Myeloid LeukemiaPhase 2ALFA2101NCT05260528

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

A Phase 2 study testing Cytarabine and Idarubicin and CPX-315 in people with Acute Myeloid Leukemia, run by Centre Hospitalier Universitaire de Nice at 35 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Cytarabine and Idarubicin and CPX-315
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
35 sitesFrance
Study dates
3 May 2023to 2 Feb 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • De novo AML
  • No MRC-defining cytogenetic lesion
  • No t(15;17), t(8;21), inv(16) or t(16;16)
  • No NPM1 gene mutation
  • No FLT3 mutated AML (FLT3 ITD or TKD)
  • Not previously treated except for short course hydroxyurea in patients presenting with high WBC count and/or tumor symptoms,
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  • Age ≥ 50 years,
  • Performance status ≤ 2 (ECOG grading),
  • Patient must have adequate organ function as indicated detailed with laboratory values in the section IV of the protocol
  • 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.
  • 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
  • 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 .
  • Patient is available for periodic blood sampling, study related assessments, and appropriate clinical management at the treating institution for the duration of the study.
  • Patient has the ability to understand and willingness to sign an informed consent form indicating the investigational nature of the study.
  • Patient registered to the French Social Security.

Who cannot join

  • Prior history of documented MDS, MPN or MDS/MPN, tAML
  • Prior history of radiation therapy or chemotherapy for a solid tumor or lymphoma (exceptions to be considered: local radiotherapy for prostate cancer)
  • Patient has active and uncontrolled infection.
  • 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.
  • 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.
  • Patient has known human immunodeficiency virus (HIV) infection or HIV-related malignancy.
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  • Patient has clinically active hepatitis B or hepatitis C infection.
  • Patient has a known allergy or hypersensitivity to any component of CPX-351, idarubicin or cytarabine.
  • 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.
  • Patients with clinical evidence of CNS leukemia.
  • Cardiac ejection fraction <50% or considered as abnormal by echocardiography or multi-gated acquisition (MUGA) scan.
  • Patient is pregnant or breastfeeding within the projected duration of the study.

Trial locations and contacts

35 sites in 1 country. Contact the study team or a site near you to ask about taking part.

valerie Foussat contact

+33492034011

foussat.v@chu-nice.fr

35 sites in 1 country

France35 sites, 35 recruiting

  • CHU Amiens Picardie site Sud

    Amiens

    Delphine Lebon

    Delphine Lebon

    Recruiting

  • CHU d'Angers

    Angers

    Mathilde Hunault

    Mathilde Hunault, MD

    Not yet recruiting

  • CH Avignon

    Avignon

    Safia Chebrek

    Safia Chebrek

    Recruiting

  • CHRU Jean Minjoz

    Besançon

    Yohan Desbrosses

    Yohan Desbrosses

    Recruiting

  • Centre Hospitalier de Béziers

    Béziers

    Alain Saad

    Alain Saad

    Recruiting

  • Hôpital Avicenne APHP

    Bobigny

    Thorsten Braun

    Thorsten Braun

    Recruiting

  • Institut d'hématologie de Basse Normandie (IHBN)

    Caen

    Sylvain Chantepie

    Sylvain Chantepie

    Recruiting

  • Hôpital d'Instruction des Armée (HIA)

    Clamart

    Pierre Arnautou

    Pierre Arnautou

    Recruiting

  • CHU Estaing

    Clermont-Ferrand

    Romain Guieze

    Romain Guieze

    Recruiting

  • Centre Hospitalier Sud Francilien (CHSF)

    Corbeil-Essonnes

    Célia Salanouba

    Célia Salanouba

    Recruiting

  • CHU Henri Mondor

    Créteil

    Cécile Pautas

    Cécile Pautas

    Recruiting

  • Centre Hospitalier de Versailles, Site André Mignot

    Le Chesnay

    Juliette Lambert

    Juliette Lambert

    Recruiting

  • Hôpital Claude HURIEZ, CHU Lille

    Lille

    Celine Berthon

    Celine Berthon

    Recruiting

  • CHU de Limoges

    Limoges

    Pascal Turlure

    Pascal Turlure

    Recruiting

  • Hoptial de la Conception APHM

    Marseille

    Regis Costello

    Regis Costello

    Recruiting

  • Institut Paoli Calmettes

    Marseille

    Yosr Hicheri, MD

    Yosr Hicheri

    Recruiting

  • CHR Metz-Thionville Site Mercy

    Metz

    Houria Debarri

    Houria Debarri

    Recruiting

  • Groupe hospitalier de la région de Mulhouse et Sud-Alsace, Hôpital Emile Muller

    Mulhouse

    Mario Ojeda-Uribe

    Mario Ojeda-Uribe

    Recruiting

  • CHU de Nantes

    Nantes

    Pierre Peterlin

    Pierre Peterlin, MD

    Not yet recruiting

  • Centre Antoine Lacassagne

    Nice

    Lauris Gastaud

    Lauris Gastaud

    Not yet recruiting

  • CHU de Nice

    Nice

    Thomas Cluzeau, MD

    Thomas Cluzeau

    Recruiting

  • Institut de cancérologie du Gard

    Nîmes

    Samy Chraibi

    Samy Chraibi

    Recruiting

  • CHR Orléans

    Orléans

    Diana Carp

    Diana Carp

    Recruiting

  • Hopital Necker

    Paris

    Ambroise Marcais

    Ambroise Marcais

    Recruiting

  • Hôpital de la Pitié Salpêtrière

    Paris

    Madalina Uzunov

    Madalina Uzunov

    Recruiting

  • Hôpital Saint-Antoine

    Paris

    Ollivier Legrand

    Ollivier Legrand

    Recruiting

  • Hôpital Saint-Louis

    Paris

    Florence Rabian

    Florence Rabian

    Recruiting

  • CHU de Bordeaux

    Pessac

    Arnaud Pigneux, MD

    Arnaud Pigneux, MD

    Recruiting

  • Hopital Lyon Sud

    Pierre-Bénite

    Mael Heiblig

    Mael Heiblig

    Recruiting

  • CH de Roubaix

    Roubaix

    Julia Hieulle

    Julia Hieulle

    Recruiting

  • Centre Henri Becquerel

    Rouen

    Emilie Lemasle-Hue

    Emilie Lemasle-Hue

    Recruiting

  • CHU de Saint Etienne

    Saint-Priest-en-Jarez

    Emmanuelle Tavernier

    Emmanuelle Tavernier

    Recruiting

  • CHU de Toulouse

    Toulouse

    Sarah Bertoli

    Sarah Bertoli, MD

    Recruiting

  • Hopital Bretonneau

    Tours

    Alban Villate

    Alban Villate

    Recruiting

  • Institut Gustave Roussy

    Villejuif

    Sephane De Botton

    Stéphane De Botton

    Recruiting

Other trials in France

About this study

Official title: 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

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

Read the detailed description

Acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy characterized by clonal expansion of myeloid blasts.

Interestingly comparing de novo and stringently defined secondary AMLs occurring after a documented phase of MDS, Lindsley et al. could identify among de novo AMLs a molecular subgroup, termed 'secondary-type AML', defined by mutations in either SRSF2, SF3B1, U2AF1, ZRSR2, ASXL1, EZH2, BCOR and/or STAG2 genes. Among de novo AML patients, 33.3% had secondary-type mutations.

It has been shown that patients older than 60 years of age harboring secondary-type AML, as defined by this 8-gene molecular signature, had inferior outcome to those without 'secondary-type' mutations when treated with conventional 7+3 chemotherapy, combining cytarabine and an anthracycline (ALFA 1200 study). This was notably true among patients with 'intermediate-risk' disease per European LeukemiaNet criteria.

The incidence of 'secondary-type' AML mutations increases with age and with cytogenetic risk category. Notably, roughly 50% of de novo AML patients with intermediate risk older than 50 years of age harbor such secondary-type mutations, New therapeutic options are thus necessary in patients older than 50 years with de novo AML classified adverse risk but also intermediate risk and associated to secondary-type mutation

This study will evaluate the rate of MRD negative remissions with CPX-351 used as induction and consolidation therapy according to its marketing authorization (AMM), as compared to intensive chemotherapy in a population of non-MRC AMLs enriched in secondary-like mutations. In addition,P-gp activity will be explore as a putative biomarker.

Being tested
Cytarabine and Idarubicin, CPX-315
Keywords
CPX-351, Acute Myeloid Leukemia
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cytarabine and IdarubicinDrug

    Also called Standard arm

    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

  • CPX-315Drug

    Also called Investigational arm

    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

Study groups in NCT05260528
Study groupRoleWhat they receive
Standard armActive comparatorconventional 7+3 chemotherapy
Receives: Drug: Cytarabine and Idarubicin
Investigational armExperimentalCPX-351
Receives: Drug: CPX-315

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in the proportion of patients achieving deep remission (CR)/(CRi) with a standardized flow based MRD in the BM aspirate using the LAIP/Dfn method after the 1st induction

    Measured: 28-56 days

Secondary outcomes (18)

  1. Rate of CR/CRi with a flow based MRD in the BM aspirate using the LAIP/Dfn method

    Measured: 28-56 days

  2. Analysis of rate of flow-based MRD quantified in the bone marrow according to both the LAIP/DfN method and the LSC method

    Measured: 10-13 weeks

  3. Analysis of flow-based MRD quantified according to both LAIP/DfN method and the LSC methods

    Measured: 10-13 weeks

  4. Overall response rate, and CR and CRi rates

    Measured: 28-56 days

  5. Cumulative incidence of allogeneic HSCT

    Measured: 4.5 years

  6. Early mortality at D30, D60, D100

    Measured: day 100

  7. Overall Survival (with and without censoring at allogeneic HSCT)

    Measured: 4.5 years

  8. Relapse-Free Survival (with and without censoring at allo-HSCT)

    Measured: 4.5 years

  9. Event-Free Survival (with and without censoring at allo-HSCT)

    Measured: 4.5 years

  10. Cumulative Incidence of Relapse (with and without censoring at allo-HSCT)

    Measured: 4.5 years

  11. Analysis of Hematological and non-hematological toxicity profile and safety using the NCI- common toxicity criteria (CTCAE) version 5.0 of November 2017

    Measured: 4.5 years

  12. Analysis of duration of hospitalization during induction and consolidation cycles

    Measured: 6 months

  13. Analysis of changes of the genomic landscape with the treatment

    Measured: 6 months

  14. Analysis of the somatic mutations (documented with their allele frequency) associated with AML and OS, RFS

    Measured: 4.5 years

  15. QoL EORTC QLQ-C30 ( core quality of life questionnaire developped by European Organization for Research and treatment of Cancer), Self assessment by patients

    The EORTC QLQ-C30nsubscales scores are tranformed to a 0 to 100 scale, with higher score on functionnal scales indicating better function and higher scores on sumptom scales indicating worse symptoms

    Measured: 6 months

  16. Analysis of secondary-type mutational profile at screening as determined by Lindsley et al

    Exploratory objectives

    Measured: 6 months

  17. Analysis of entralized functional flow cytometry assays at baseline carried on peripheral blood or bone marrow aspirate

    Exploratory objectives

    Measured: 6 months

  18. Analysis of Flow MRD

    Exploratory objectives

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start3 May 2023
  3. Primary completion2 Aug 2028 (estimated)
  4. Study completion2 Feb 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
248 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05260528
Sponsor's protocol ID
21-PP-26
Acronym
ALFA2101
Status last verified
Mar 2026
First submitted
7 Feb 2022
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cytarabine and Idarubicin and CPX-315 in people with Acute Myeloid Leukemia, run by Centre Hospitalier Universitaire de Nice at 35 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact valerie Foussat (+33492034011, foussat.v@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in the proportion of patients achieving deep remission (CR)/(CRi) with a standardized flow based MRD in the BM aspirate using the LAIP/Dfn method after the 1st induction (time frame: 28-56 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05260528.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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