The CLARA Study From the Acute Leukemia French Association (ALFA 0702 Trial)
Conditions
Acute Myeloid Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
Younger Patients with Newly-Diagnosed Acute Myeloid Leukemia (AML).
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: CLARA Type: Drug
Name: HDAc Type: Drug
Overall Status
Recruiting
Summary
This study is a phase II randomized multicenter study. Patients will be enrolled at time of diagnosis and will receive one or two cycles of induction chemotherapy. Patients, without indication of intensification by allogeneic stem cell transplantation and/or without HLA (Human Leukocyte Antigen)-compatible donor, who attain a CR after one or two cycles of induction chemotherapy, will be eligible for the study Clofarabine / Intermediate-Dose Cytarabine (CLARA)versus High-Dose Cytarabine (HDAC)and will be randomized between 3 courses of CLARA chemotherapy and 3 courses of HDAC chemotherapy as consolidation.

We will compare efficacy and toxicity among the two arms.
Detailed Description
Because of the results of our former trial (ALFA-9802) [Thomas, 2005], chemotherapy will be combined in each arm with G-CSF (Granulocyte Colony-Stimulating Factor) given during each sequence of chemotherapy in order to increase the blast priming.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 60 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria at registration:

1. Age 18 years or more and less than 60 years

2. With:

A morphologically proven diagnosis of AML according to the WHO classification, cytogenetically (standard karyotype, FISH-MLL) and molecularly (FLT3, CEBPA, NMP1) defined.

3. ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2.

4. Have adequate renal and hepatic function as indicated by the following laboratory values:

- Creatinine clearance (calculated by the cockcroft and Gault method) ≥ 40mL/min;

- AST (Aspartate amino transférase) and ALT (Alanine Amino Transférase ) < or = 2.5N; total bilirubin < or = 2N (unless related to the underlying disease).

5. Cardiac function determined by radionuclide or echography within normal limits.

6. Women of child-bearing potential (i.e. women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods, and must have a negative serum or urine pregnancy test within 2 weeks prior the beginning treatment on this trial.

7. Must be able and willing to give written informed consent.

8. The subject must be covered by a social security system.

Exclusion Criteria at registration:

1. Patients with AML with favorable risk cytogenetics: M3-AML; CBF-AML including t(8:21), inv(16), or t(16;16) AML.

2. Ph-positive AML.

3. AML following diagnosed myeloproliferation or patient with prior history of MDS known for more than 3 months

4. Prior treatment with chemotherapy or radiotherapy for another tumor.

5. Prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma

6. Compromised organ function judged to be lifethreatening by the Investigator.

7. Positive serology for HIV (Human Immunodeficiency Virus), HBV (Hepatitis B Virus) and HBC (Hepatitis C Virus)(except post vaccination)

8. Uncontrolled active infection of any kind or bleeding. Patients with infections who are under active treatment with antibiotics and whose infections are controlled may be entered to the study.

9. Other active malignancy.

10. Patients concurrently receiving any other standard or investigational treatment for their leukemia, with the exception of hydroxyurea.

INCLUSION CRITERIA AT RANDOMIZATION

1. Patients with either in first CR/CRp after the first induction course or in first CR/CRp after salvage therapy.

2. ECOG performance status 0 to 2.

3. AST and ALT < or = 2.5N; total bilirubin < or = 2N.

4. Creatinine clearance ≥40mL/min (calculated by the cockcroft and Gault method or by MDRD (see http://nephron.org/cgi-bin/MDRD_GFR/cgi)

5. Patient without HLA identical donor.

EXCLUSION CRITERIA AT RANDOMIZATION

6. Patients belonging to the intermediate 1 risk group (CEBPA+ or NPM1+ without Flt3-ITD) in CR/CRp after the first induction course. These patients will go out of the study and receive consolidation cycles based on HD-AraC (Aracytine).

7. Known central nervous system involvement with AML.

8. Uncontrolled active infection of any kind or bleeding.

9. Compromized organ function judged to be lifethreatening by the Investigator.

10. Patient with HLA identical donor identified.
Locations
Hôpital Sud - CHU Amiens
Amiens, France
Status: Recruiting
Centre Hospitalier Regional et Universitaire d'Angers
Angers, France
Status: Recruiting
Hôpital Victor Dupouy
Argenteuil, France
Status: Recruiting
Hôpital Avicenne - bobigny
Bobigny, France
Status: Recruiting
Centre Hospitalier Boulogne/Mer
Boulogne / Mer, France
Status: Recruiting
Hôpital Clemenceau - chu Caen
Caen, France
Status: Recruiting
Centre Hospitalier René Dubos
Cergy Pontoise, France
Status: Recruiting
HIA Percy
Clamart, France
Status: Recruiting
Hôpital de Corbeil
Corbeil, France
Status: Recruiting
Hôpital Mondor
Créteil, France
Status: Recruiting
Hôpital Dubocage
Dijon, France
Status: Recruiting
Centre Hospitalier Dunkerque
Dunkerque, France
Status: Recruiting
Hôpital Michallon
Grenoble, France
Status: Recruiting
Centre Hospitalier Versailles
Le Chesnay, France
Status: Recruiting
Centre Hospitalier Schaffner
Lens, France
Status: Recruiting
Hôpital Huriez
Lille, France
Status: Recruiting
CHU Dupuytren
Limoges, France
Status: Recruiting
Institut Paoli-Calmette
Marseille, France
Status: Not yet recruiting
Centre Hospitalier Meaux
Meaux, France
Status: Recruiting
CHU - Hôtel Dieu
Nantes, France
Status: Recruiting
Centre A. Lacassagne
Nice, France
Status: Recruiting
Hôpital Archet 1
Nice, France
Status: Recruiting
Hôpital St Louis
Paris, France
Status: Recruiting
Contact: CELLI-LEBRAS Karine - 01 57 27 67 17 - karine.celli-lebras@sls.aphp.fr
Paris Necker
Paris, France
Status: Recruiting
Pitié-Salpetrière
Paris, France
Status: Recruiting
Hôpital Haut Lévêque
Pessac, France
Status: Recruiting
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
Pierre-benite, France
Status: Recruiting
Contact: EL HAMRI Mohamed - mohamed.el-hamri@chu-lyon.fr
Hôpital V. Provo
Roubaix, France
Status: Recruiting
Centre Henri Becquerel - CHRU ROUEN
Rouen, France
Status: Recruiting
Centre Hospitalier Huguenin
Saint Cloud, France
Status: Recruiting
Hôpital Purpan
Toulouse, France
Status: Recruiting
Centre Hospitalier Valenciennes
Valenciennes, France
Status: Recruiting
CHU de Brabois
Vandoeuvre Les Nancy, France
Status: Recruiting
Institut Gustave Roussy
Villejuif, France
Status: Recruiting
Start Date
March 2009
Completion Date
September 2015
Sponsors
Hospices Civils de Lyon
Source
Hospices Civils de Lyon
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page