Full Text View
Tabular View
No Study Results Posted
Related Studies
The CLARA Study From the Acute Leukemia French Association (ALFA 0702 Trial)
This study is currently recruiting participants.
Verified by Hospices Civils de Lyon, July 2009
First Received: July 2, 2009   No Changes Posted
Sponsored by: Hospices Civils de Lyon
Information provided by: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00932412
  Purpose

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-compatible donor, who attain a CR after one or two cycles of induction chemotherapy, will be eligible for the study CLARA versus 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.


Condition Intervention Phase
Acute Myeloid Leukemia
Drug: clofarabine
Drug: HDAc
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized Phase II Study of Clofarabine / Intermediate-Dose Cytarabine (CLARA)Versus High-Dose Cytarabine (HDAC) as Consolidation in Younger Patients With Newly-Diagnosed Acute Myeloid Leukemia (AML).

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • The primary objective of this randomized Phase 2 study is the 2-year DFS (disease free survival) following first remission achievement (CR or CRp) in younger patients with intermediate-risk or unfavorable-risk AML. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • • Safety profile of CLARA versus HDAC consolidation courses [ Designated as safety issue: Yes ]
  • • Possible predictors to response: with respect to cytogenetics risk groups and mutational status (FLT3, MLL, CEBPA and NPM) [ Designated as safety issue: Yes ]
  • • MRD level after 2 courses of consolidation [ Designated as safety issue: Yes ]
  • • Relationship between minimal residual disease and relapse of AML [ Designated as safety issue: Yes ]
  • • Overall cumulative incidence of relapse at 120 days [ Designated as safety issue: Yes ]
  • • Overall survival at 2 years [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: March 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Clofarabine: Experimental
Clofarabine Cytarabine G-CSF
Drug: clofarabine
Clofarabine 30 mg/m2/day IV (2h) on days 2 to 6 (administered as a 2h infusion in 250 ml of 0.9% normal saline solution) Cytarabine 1 g/m2/day IV (2h) 4 hours later on days 1 to 5 (administered as a 2h infusion in 250 ml of 5% dextrose in water) G-CSF 5 microg/kg/day IV from day 1 to day 6 (administered as a 30 mn infusion in 20 ml of dextrose 5% in water)
High Dose Aracytine: Active Comparator
Cytarabine G-CSF
Drug: HDAc
Cytarabine 3 g/m2/12h IV (3h) on days 1, 3, 5 (administered as a 3h infusion in 250 ml of 5% dextrose in water) G-CSF 5 microg/kg/day IV from day 1 to day 5 (administered as a 30 mn infusion in 20 ml of dextrose 5% in water)

Detailed Description:

Because of the results of our former trial (ALFA-9802) [Thomas, 2005], chemotherapy will be combined in each arm with G-CSF given during each sequence of chemotherapy in order to increase the blast priming.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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 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 and ALT < 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:

  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, HBV and HBC (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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932412

Contacts
Contact: Xavier THOMAS, MD 04 72 11 73 24 ext +33 xavier.thomas@chu-lyon.fr

Locations
France
Hospices Civils de Lyon - Hôpital Edouard Herriot Recruiting
LYON, France, 69437
Contact: EL HAMRI Mohamed         mohamed.el-hamri@chu-lyon.fr    
Principal Investigator: THOMAS Xavier, MD            
Hôpital Sud - CHU Amiens Not yet recruiting
Amiens, France, 80054
Principal Investigator: MAROLLEAU Jean Pierre, MD            
Hôpital Victor Dupouy Not yet recruiting
Argenteuil, France, 95107
Principal Investigator: SUTTON Laurent, MD            
Hôpital Avicenne - bobigny Recruiting
BOBIGNY, France, 93009
Principal Investigator: FENAUX Pierre, MD            
Hôpital Clemenceau - chu Caen Recruiting
CAEN, France, 14033
Principal Investigator: REMAN Oumédaly, MD            
HIA Percy Not yet recruiting
Clamart, France, 92141
Principal Investigator: DE REVEL Thierry, MD            
Hôpital de Corbeil Not yet recruiting
CORBEIL, France, 91100
Principal Investigator: DEVIDAS Alain, MD            
Hôpital Mondor Recruiting
Créteil, France, 94010
Principal Investigator: CORDONNIER Catherine, MD            
Hôpital Dubocage Not yet recruiting
Dijon, France, 21000
Principal Investigator: CAILLOT Denis, MD            
Centre Hospitalier Dunkerque Not yet recruiting
Dunkerque, France, 59395
Principal Investigator: BEAUMONT Marie, MD            
Centre Hospitalier Schaffner Not yet recruiting
LENS, France, 62307
Principal Investigator: DUPRIEZ Brigitte, MD            
Hôpital Huriez Recruiting
LILLE, France, 59037
Principal Investigator: QUESNEL Bruno, MD            
Institut Gustave Roussy Not yet recruiting
Villejuif, France, 94800
Principal Investigator: DE BOTTON Stéphane, MD            
Centre Hospitalier Meaux Not yet recruiting
MEAUX, France, 77104
Principal Investigator: FRAYFER Jamilé, MD            
Centre A. Lacassagne Recruiting
NICE, France, 06100
Principal Investigator: THYSS Antoine, MD            
Hôpital St Louis Recruiting
PARIS, France, 75010
Contact: CELLI-LEBRAS Karine     01 57 27 67 17 ext +33     karine.celli-lebras@sls.aphp.fr    
Principal Investigator: DOMBRET Hervé, MD            
Paris Necker Not yet recruiting
Paris, France, 75743
Principal Investigator: HERMINE Olivier, MD            
Pitié-Salpetrière Not yet recruiting
Paris, France, 75013
Principal Investigator: DHEDIN Nathalie, MD            
Hôpital V. Provo Not yet recruiting
Roubaix, France, 59056
Principal Investigator: PLANTIER Isabelle, MD            
Centre Hospitalier Huguenin Recruiting
Saint Cloud, France, 92210
Principal Investigator: JANVIER Maud, MD            
Centre Hospitalier St Quentin Not yet recruiting
Saint Quentin, France, 02321
Principal Investigator: GARIDI Réda, MD            
Centre Hospitalier Valenciennes Recruiting
Valenciennes, France, 59322
Principal Investigator: SIMON Marc, MD            
Centre Hospitalier Versailles Recruiting
LE CHESNAY, France, 78150
Principal Investigator: CASTAIGNE Sylvie, MD            
CHU Dupuytren Recruiting
Limoges, France, 87042
Principal Investigator: BORDESSOULE Dominique, MD            
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Xavier THOMAS, MD Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
Study ID Numbers: 2006.456/50
Study First Received: July 2, 2009
Last Updated: July 2, 2009
ClinicalTrials.gov Identifier: NCT00932412     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:
Younger Patients with Newly-Diagnosed Acute Myeloid Leukemia (AML).

Study placed in the following topic categories:
Antimetabolites
Clofarabine
Anti-Infective Agents
Leukemia
Acute Myelocytic Leukemia
Immunologic Factors
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Immunosuppressive Agents
Antiviral Agents
Cytarabine

Additional relevant MeSH terms:
Clofarabine
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Leukemia
Neoplasms
Therapeutic Uses
Cytarabine

ClinicalTrials.gov processed this record on September 10, 2009