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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

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

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.

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)

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