Informations générales (source: ClinicalTrials.gov)
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 (ALFA2101)
Interventional
Phase 2
Centre Hospitalier Universitaire de Nice (Voir sur ClinicalTrials)
mai 2023
octobre 2027
29 juin 2024
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 (according to 2017 ELN criteria)
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | St�phane DE BOTTON | 05/06/2024 07:58:23 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Avicenne | Thorsten Braun | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Necker-Enfants Malades | Ambroise Marcais | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Saint Antoine | Ollivier Legrand | Contact (sur clinicalTrials) | |||
| CH DE VERSAILLES SITE ANDRE MIGNOT | Juliette Lambert | Contact (sur clinicalTrials) | |||
| CTRE EXAMENS SANTE CORBEIL ESSONNES | Stéphanie Haiat | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH de Roubaix - Roubaix - France | Isabelle Plantier | Contact (sur clinicalTrials) | |||
| CHR Orléans - Orléans - France | Diana Carp | Contact (sur clinicalTrials) | |||
| CHRU Jean Minjoz - Besançon - France | Yohan Desbrosses | Contact (sur clinicalTrials) | |||
| CHU Amiens Picardie site Sud - Amiens - France | Delphine Lebon | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - Nice - France | Lauris Gastaud | Contact (sur clinicalTrials) | |||
| Centre Henri Becquerel - Rouen - France | Emilie Lemasle-Hue | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Béziers - Béziers - France | Alain Saad | Contact (sur clinicalTrials) | |||
| CH Avignon - Avignon - France | Safia Chebrek | Contact (sur clinicalTrials) | |||
| CHR Metz-Thionville Site Mercy - Metz - France | Houria Debarri | Contact (sur clinicalTrials) | |||
| CHU de Limoges - Limoges - France | Pascal Turlure | Contact (sur clinicalTrials) | |||
| CHU de Nice - Nice - France | Thomas Cluzeau, MD | Contact (sur clinicalTrials) | |||
| CHU de Saint Etienne - Saint-Priest-en-Jarez - France | Emmanuelle Tavernier | Contact (sur clinicalTrials) | |||
| CHU Estaing - Clermont Ferrand - France | Romain Guieze | Contact (sur clinicalTrials) | |||
| CHU Henri Mondor - Créteil - France | Cécile Pautas | Contact (sur clinicalTrials) | |||
| Groupe hospitalier de la région de Mulhouse et Sud-Alsace, Hôpital Emile Muller - Mulhouse - France | Mario Ojeda-Uribe | Contact (sur clinicalTrials) | |||
| Hopital Bretonneau - Tours - France | Alban Villate | Contact (sur clinicalTrials) | |||
| Hôpital Claude HURIEZ, CHU Lille - Lille - France | Celine Berthon | Contact (sur clinicalTrials) | |||
| Hôpital de la Pitié Salpêtrière - Paris - France | Madalina Uzunov | Contact (sur clinicalTrials) | |||
| Hôpital d'Instruction des Armée (HIA) - Clamart - France | Pierre Arnautou | Contact (sur clinicalTrials) | |||
| Hopital Lyon Sud - Pierre-Bénite - France | Mael Heiblig | Contact (sur clinicalTrials) | |||
| Hôpital Saint-Louis - Paris - France | Florence Rabian | Contact (sur clinicalTrials) | |||
| Hoptial de la Conception APHM - Marseille - France | Regis Costello | Contact (sur clinicalTrials) | |||
| Institut de cancérologie du Gard - Nîmes - France | Samy Chraibi | Contact (sur clinicalTrials) | |||
| Institut d'hématologie de Basse Normandie (IHBN) - Caen - France | Sylvain Chantepie | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
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.
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.