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Sponsored by: |
Groupe Francophone des Myelodysplasies |
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Information provided by: | Groupe Francophone des Myelodysplasies |
ClinicalTrials.gov Identifier: | NCT00411905 |
We are evaluating the efficacy of the association of Low dose Cytarabine in association with Bortezomib in the treatment of patients diagnosed with high risk Myelodysplastic syndromes. Our aim is to decrease transfusion requirements and if possible induce a complete or at least a partial remission.
Condition | Intervention | Phase |
---|---|---|
Myelodysplastic Syndromes |
Drug: Bortezomib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes |
Estimated Enrollment: | 39 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2006 |
Four cycles of treatment are proposed at 28 day intervals in an ambulatory setting
Cycle 1 :
Cycles 2, 3, 4 :
Bone marrow aspirates are evaluated just before the first cycle, after the second and after the fourth cycles
Responding patients may continue the treatment for 2 further cycles
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shanti Natarajan-Amé, MD | 00 33 3 88 12 76 70 | shanti.ame@chru-strasbourg.fr |
Contact: Marjorie Sidhoum, CRA | 00 33 3 88 12 81 48 | marjorie.sidhoum@chru-strasbourg.fr |
France | |
Centre Hospitalier Universitaire de STRASBOURG | Recruiting |
Strasbourg, France, 67098 | |
Contact: Shanti NATARAJAN-AME, MD 00 33 3 88 12 76 70 shanti.ame@chru-strasbourg.fr | |
Contact: Marjorie SIDHOUM, CRA 00 33 3 88 12 81 48 marjorie.sidhoum@chru-strasbourg.fr | |
Principal Investigator: Shanti NATARAJAN-AME, MD | |
Hopital Cochin | Recruiting |
PARIS, France, 75014 | |
Contact: FRANCOIS DREYFUS, Profesor 00 33 1 58 41 21 20 francois.dreyfus@ch.aphp.fr | |
Contact: Nathalie Klein, CRE 00 33 1 58 41 20 44 nathalie.klein@cch.aphp.fr | |
Principal Investigator: François DREYFUS, Profesor | |
CHU de Limoges | Not yet recruiting |
Limoges, France, 87046 | |
Contact: Dominique BORDESSOULE, Profesor 00 33 5 55 05 66 42 bordessoule@unilim.fr | |
Principal Investigator: Dominique BORDESSOULE, Profesor | |
CHU Brabois | Recruiting |
Vandoeuvre, France, 54511 | |
Contact: Agnes GUERCI-BRESLER, MD 00 33 3 83 15 3281 a.guerci@chu-nancy.fr | |
Principal Investigator: Agnes GUERCI-BRESLER, MD | |
CHU Dijon | Recruiting |
Dijon, France, 21000 | |
Contact: Elisabeth BERGER, MD 00 33 3 80 29 50 41 elisabeth.berger@chu-dijon.fr | |
Contact: Monique Grandjean, CRE 00 33 80 29 50 47 monique.grandjean@chu-dijon.fr | |
Sub-Investigator: Eric SOLARY, MD | |
Principal Investigator: Elisabeth BERGER, MD | |
CHU Purpan | Not yet recruiting |
Toulouse, France, 31059 | |
Contact: Guy Laurent, MD 00 33 5 61 77 20 78 beynerauzy.o@chu-toulouse.fr | |
Principal Investigator: Guy LAURENT, MD | |
Sub-Investigator: Odile BEYNE-RAUZY, MD | |
Hopital Avicenne | Recruiting |
Bobigny, France, 93009 | |
Contact: Pierre FENAUX, MD 00 33 1 48 95 70 50 pierre.fenaux@avc.aphp.fr | |
Contact: Fatima Hamza, CRA 00 33 1 48 95 58 90 fatima.hamza@avc.aphp.fr | |
Principal Investigator: Pierre FENAUX, MD PhD | |
Institut Bergonie | Not yet recruiting |
Bordeaux, France, 33076 | |
Contact: Josy REIFFERS, Profesor 00 33 05 56 33 33 00 reiffers@bergonie.org | |
Contact: Gabriel ETIENNE, MD 00 33 5 56 33 44 19 gabriel.etienne@chu-bordeaux.fr | |
Principal Investigator: Josy Reiffers, Profesor | |
Sub-Investigator: Gabriel ETIENNE, MD | |
Hopital Paoli Calmette | Recruiting |
Marseille, France, 13273 | |
Contact: Norbert VEY, MD 00 33 4 31 22 36 95 veyn@marseille.fnclcc.fr | |
Principal Investigator: Norbert VEY, MD | |
Sub-Investigator: Aude CHARBONNIER, MD | |
Sub-Investigator: Reda BOUABDALLAH, MD | |
CHU Archet | Not yet recruiting |
Nice, France, 06202 | |
Contact: Laurence LEGROS, DOCTOR 00 33 4 92 03 58 44 legros@nice.fr | |
Principal Investigator: Laurence LEGROS, MD | |
CHU de Caen | Not yet recruiting |
Caen, France, 14033 | |
Contact: Stéphane CHEZE, MD 00 33 2 31 27 23 60 cheze-s@chu-caen.fr | |
Principal Investigator: Stéphane CHEZE, MD | |
Centre Henry Becquerel | Active, not recruiting |
ROUEN, France, 76038 | |
CHU Albert Michallon | Recruiting |
Grenoble, France, 38043 | |
Contact: Jean-Yves CAHN, Professor 00 33 4 76 76 94 45 JYCahn@chu-grenoble.fr | |
Contact: Stephane COURBY, MD 00 33 4 76 76 59 53 Scourby@chu-grenoble.fr | |
Principal Investigator: Jean-Yves CAHN, MD | |
Centre Hospitalier Joffre | Not yet recruiting |
Perpignan, France, 66046 | |
Contact: Laurence Sanhes, MD 00 33 468616448 laurence.sanhes@ch-perpignan.fr | |
Principal Investigator: Laurence Sanhes, MD | |
CHU Angers | Not yet recruiting |
Angers, France, 43033 | |
Contact: Mathilde HUNAULT-BERGER, Professor 00 33 241354475 MaHunault@chu-angers.fr | |
Contact: Martine Gardembas-Pain, MD 00 33 241354705 MaGardembas@chu-angers.fr | |
Principal Investigator: Mathilde HUNAULT-BERGER, MD PhD |
Principal Investigator: | Francois DREYFUS, MD PhD | Groupe francaise des Myelodysplasies |
Study ID Numbers: | GFM BAR-C-2005 |
Study First Received: | December 14, 2006 |
Last Updated: | March 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00411905 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Myelodysplastic syndromes IPSS Int-2 and High risk Bortezomib Low dose Cytarabine Bone Marrow diseases |
Antimetabolites Preleukemia Immunologic Factors Precancerous Conditions Hematologic Diseases Bortezomib |
Myelodysplastic Syndromes Bone Marrow Diseases Immunosuppressive Agents Antiviral Agents Cytarabine Protease Inhibitors |
Antimetabolites Anti-Infective Agents Disease Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Precancerous Conditions Antineoplastic Agents Hematologic Diseases Physiological Effects of Drugs Myelodysplastic Syndromes Bortezomib |
Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Protease Inhibitors Preleukemia Neoplasms Pathologic Processes Therapeutic Uses Syndrome Bone Marrow Diseases Cytarabine |