CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics
ALFA2101
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
1 other identifier
interventional
248
1 country
35
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2023
Longer than P75 for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2022
CompletedFirst Posted
Study publicly available on registry
March 2, 2022
CompletedStudy Start
First participant enrolled
May 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 2, 2030
March 27, 2026
March 1, 2026
5.3 years
February 7, 2022
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
28-56 days
Secondary Outcomes (18)
Rate of CR/CRi with a flow based MRD in the BM aspirate using the LAIP/Dfn method
28-56 days
Analysis of rate of flow-based MRD quantified in the bone marrow according to both the LAIP/DfN method and the LSC method
10-13 weeks
Analysis of flow-based MRD quantified according to both LAIP/DfN method and the LSC methods
10-13 weeks
Overall response rate, and CR and CRi rates
28-56 days
Cumulative incidence of allogeneic HSCT
4.5 years
- +13 more secondary outcomes
Study Arms (2)
Standard arm
ACTIVE COMPARATORconventional 7+3 chemotherapy
Investigational arm
EXPERIMENTALCPX-351
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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,
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acute Leukemia French Associationcollaborator
- Centre Hospitalier Universitaire de Nicelead
- Jazz Pharmaceuticalscollaborator
Study Sites (35)
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
CHU de Nice
Nice, France
Institut de cancérologie du Gard
Nîmes, France
CHR Orléans
Orléans, France
Hopital Necker
Paris, France
Hôpital de la Pitié Salpêtrière
Paris, France
Hôpital Saint-Antoine
Paris, France
Hôpital Saint-Louis
Paris, France
CHU de Bordeaux
Pessac, France
Hopital Lyon Sud
Pierre-Bénite, France
CH de Roubaix
Roubaix, France
Centre Henri Becquerel
Rouen, France
CHU de Saint Etienne
Saint-Priest-en-Jarez, France
CHU de Toulouse
Toulouse, France
Hopital Bretonneau
Tours, France
Institut Gustave Roussy
Villejuif, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Cluzeau, MD
Centre Hospitalier Universitaire de Nice
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2022
First Posted
March 2, 2022
Study Start
May 3, 2023
Primary Completion (Estimated)
August 2, 2028
Study Completion (Estimated)
February 2, 2030
Last Updated
March 27, 2026
Record last verified: 2026-03