Actively Recruiting
CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics
Led by Centre Hospitalier Universitaire de Nice · Updated on 2026-03-27
248
Participants Needed
35
Research Sites
352 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Nice
Lead Sponsor
J
Jazz Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of de novo acute myeloid leukemia (AML)
- No myelodysplasia-related cytogenetic lesions
- Absence of t(15;17), t(8;21), inv(16), or t(16;16) genetic abnormalities
- No NPM1 gene mutation
- No FLT3 mutated AML (including FLT3 ITD or TKD)
- No prior treatment except short course 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 based on laboratory tests
- Female patients of childbearing potential must have a negative pregnancy test within 72 hours before starting treatment
- Female patients must be post-menopausal, surgically sterilized, or agree to use two effective contraceptive methods during the study
- Male patients must agree to use contraception during the study and for 3 months after treatment
- Availability for periodic blood sampling and study assessments
- Ability to understand and sign informed consent
- Registered with the French Social Security system
You will not qualify if you...
- History of myelodysplastic syndrome (MDS), myeloproliferative neoplasm (MPN), or mixed MDS/MPN, or therapy-related AML
- Previous radiation therapy or chemotherapy for solid tumors or lymphoma (except local prostate radiotherapy)
- Active, uncontrolled infection
- Uncontrolled illnesses that may affect study compliance, such as symptomatic heart failure, unstable angina, or psychiatric conditions
- Participation in another investigational study within 30 days before starting treatment
- Known HIV infection or HIV-related malignancy
- Active hepatitis B or C infection
- Allergy or hypersensitivity to CPX-351, idarubicin, or cytarabine
- Currently active second cancer except nonmelanoma skin cancer or cervical carcinoma in situ
- Clinical evidence of central nervous system leukemia
- Cardiac ejection fraction below 50% or abnormal heart function by echocardiography or MUGA scan
- Pregnancy or breastfeeding during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 locations
1
CHU Amiens Picardie site Sud
Amiens, France
Actively Recruiting
2
CHU d'Angers
Angers, France
Not Yet Recruiting
3
CH Avignon
Avignon, France
Actively Recruiting
4
CHRU Jean Minjoz
Besançon, France
Actively Recruiting
5
Centre Hospitalier de Béziers
Béziers, France
Actively Recruiting
6
Hôpital Avicenne APHP
Bobigny, France
Actively Recruiting
7
Institut d'hématologie de Basse Normandie (IHBN)
Caen, France
Actively Recruiting
8
Hôpital d'Instruction des Armée (HIA)
Clamart, France
Actively Recruiting
9
CHU Estaing
Clermont-Ferrand, France
Actively Recruiting
10
Centre Hospitalier Sud Francilien (CHSF)
Corbeil-Essonnes, France
Actively Recruiting
11
CHU Henri Mondor
Créteil, France
Actively Recruiting
12
Centre Hospitalier de Versailles, Site André Mignot
Le Chesnay, France
Actively Recruiting
13
Hôpital Claude HURIEZ, CHU Lille
Lille, France
Actively Recruiting
14
CHU de Limoges
Limoges, France
Actively Recruiting
15
Hoptial de la Conception APHM
Marseille, France
Actively Recruiting
16
Institut Paoli Calmettes
Marseille, France
Actively Recruiting
17
CHR Metz-Thionville Site Mercy
Metz, France
Actively Recruiting
18
Groupe hospitalier de la région de Mulhouse et Sud-Alsace, Hôpital Emile Muller
Mulhouse, France
Actively Recruiting
19
CHU de Nantes
Nantes, France
Not Yet Recruiting
20
Centre Antoine Lacassagne
Nice, France
Not Yet Recruiting
21
CHU de Nice
Nice, France
Actively Recruiting
22
Institut de cancérologie du Gard
Nîmes, France
Actively Recruiting
23
CHR Orléans
Orléans, France
Actively Recruiting
24
Hopital Necker
Paris, France
Actively Recruiting
25
Hôpital de la Pitié Salpêtrière
Paris, France
Actively Recruiting
26
Hôpital Saint-Antoine
Paris, France
Actively Recruiting
27
Hôpital Saint-Louis
Paris, France
Actively Recruiting
28
CHU de Bordeaux
Pessac, France
Actively Recruiting
29
Hopital Lyon Sud
Pierre-Bénite, France
Actively Recruiting
30
CH de Roubaix
Roubaix, France
Actively Recruiting
31
Centre Henri Becquerel
Rouen, France
Actively Recruiting
32
CHU de Saint Etienne
Saint-Priest-en-Jarez, France
Actively Recruiting
33
CHU de Toulouse
Toulouse, France
Actively Recruiting
34
Hopital Bretonneau
Tours, France
Actively Recruiting
35
Institut Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
V
valerie Foussat
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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