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Sponsored by: |
Hospices Civils de Lyon |
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Information provided by: | Hospices Civils de Lyon |
ClinicalTrials.gov Identifier: | NCT00932412 |
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 |
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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). |
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 |
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Clofarabine: Experimental
Clofarabine Cytarabine G-CSF
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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)
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High Dose Aracytine: Active Comparator
Cytarabine G-CSF
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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)
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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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
With:
A morphologically proven diagnosis of AML according to the WHO classification, cytogenetically (standard karyotype, FISH-MLL) and molecularly (FLT3, CEBPA, NMP1) defined.
Have adequate renal and hepatic function as indicated by the following laboratory values:
Exclusion Criteria:
Contact: Xavier THOMAS, MD | 04 72 11 73 24 ext +33 | xavier.thomas@chu-lyon.fr |
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 |
Principal Investigator: | Xavier THOMAS, MD | Hospices Civils de Lyon |
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 |
Younger Patients with Newly-Diagnosed Acute Myeloid Leukemia (AML). |
Antimetabolites Clofarabine Anti-Infective Agents Leukemia Acute Myelocytic Leukemia Immunologic Factors |
Leukemia, Myeloid Leukemia, Myeloid, Acute Immunosuppressive Agents Antiviral Agents Cytarabine |
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 |