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Sponsored by: |
Groupe Francophone des Myelodysplasies |
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Information provided by: | Groupe Francophone des Myelodysplasies |
ClinicalTrials.gov Identifier: | NCT00446303 |
A phase II multicentre trial of maintenance with Azacitidine in MDS patients achieving complete or partial remission (CR or PR) after intensive chemoterapy.
The primary objective is response duration (MDS or AML)
Condition | Intervention | Phase |
---|---|---|
Leukemia, Myelocytic, Acute Myelodysplastic Syndromes |
Drug: Azacitidine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Maintenance With Azacitidine in MDS Patients Achieving Complete or Partial Remission (CR or PR) After Intensive Chemotherapy |
Estimated Enrollment: | 39 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | July 2010 |
A academic multicentre study whose aims are to study the benefits of a maintenance therapy with 24 monthly courses af azacytidine in high-risk MDS patients, previously treated with intensive chemotherapy with obtention of a partial or complete response and not eligible for allogeneic transplantation
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
AND
in CR or PR according to IWG criteria (see appendix 3) after one or two courses of predefined intensive chemotherapy (see page 12) with available cytogenetics at evaluation of response Aged 18 years of age or more Written Informed consent Adequate Contraception, if relevant Negative pregnancy test if relevant. Patients not eligible for the azacitidine confirmatory trial (azacitidine « versus » conventional treatment ») or unwilling to participate to it
Exclusion Criteria:
Contact: Claude GARDIN, MD | 0033148957054 | claude.gardin@avc.aphp.fr |
Contact: Fatima-Zohra HAMZA, CRA | 0033148955890 | fatima.hamza@avc.aphp.fr |
France | |
CHU d'Amiens | Recruiting |
Amiens, France, 80054 | |
Contact: Ghandi DAMAJ 0033322455915 damaj.Gandhi@chu-amiens.fr | |
Principal Investigator: DAMAJ, MD | |
CHU Angers | Terminated |
Angers, France, 49033 | |
CH d'Avignon | Not yet recruiting |
Avignon, France, 84000 | |
Contact: Borhane SLAMA, MD 0033432753132 bslama@ch-avignon.fr | |
Principal Investigator: SLAMA, MD | |
Hopital Haut Leveque | Suspended |
Pessac, France, 33604 | |
CHU de Caen | Recruiting |
Caen, France, 14033 | |
Contact: Stéphane CHEZE, MD 0033231272360 cheze-s@chu-caen.fr | |
Principal Investigator: CHEZE, MD | |
Hopital d'Instruction des Armées Percy | Not yet recruiting |
Clamart, France, 92140 | |
Contact: Thierry DE REVEL, Profesor 0033141466301 hematologie.percy@wanadoo.fr | |
Principal Investigator: DE REVEL, Professor | |
Hopital Henri Mondor | Recruiting |
Creteil, France, 94000 | |
Contact: Catherine CORDONNIER 0033149812057 carlcord@club-internet.fr | |
Sub-Investigator: MATHIEU KUENTZ, MD | |
Sub-Investigator: SEBASTIEN MAURY, MD | |
Sub-Investigator: CECILE PAUTAS, MD | |
Sub-Investigator: STEPHANE GIRAUDIER, MD | |
Sub-Investigator: MICHEL TULLIEZ, PROFESSOR | |
Principal Investigator: CATHERINE CORDONNIER, MD | |
CHU de Dijon | Recruiting |
Dijon, France, 21034 | |
Contact: Denis CAILLOT 0033380293645 | |
Sub-Investigator: BERGER, MD | |
Sub-Investigator: BASTIE, MD | |
Sub-Investigator: CASANOVAS, MD | |
Sub-Investigator: SOLARY, Professor | |
CHU Albert Michallon | Not yet recruiting |
Grenoble, France, 38043 | |
Contact: Jean-Yves CAHN, Professor 0033476769445 JYCahn@chu-grenoble.fr | |
Principal Investigator: CAHN, Professor | |
CHRU Hurriez | Not yet recruiting |
Lille, France, 59057 | |
Contact: Bruno QUESNEL, Profesor 0033320446640 b-quesnel@chru.fr | |
Principal Investigator: QUESNEL, Professor | |
CHRU de Limoges | Recruiting |
Limoges, France, 87046 | |
Contact: Dominique BORDESSOULE, Profesor 0033555056642 bordessoule@unilim.fr | |
Principal Investigator: Dominique BORDESSOULE, Professor | |
Sub-Investigator: Marie Pierre CHAURY, MD | |
Hopital Edouard Herriot | Not yet recruiting |
Lyon, France, 69437 | |
Contact: Youcef CHELGHOUM, MD 0033472117324 youcef-chelghoum@chu-lyon.fr | |
Sub-Investigator: MICHALLET, Professor | |
Sub-Investigator: TRONCY, MD | |
Principal Investigator: CHELGHOUM, MD | |
Hopital Saint Louis | Recruiting |
Paris, France, 75475 | |
Contact: Hervé DOMBRET, Professor 33142499643 herve.dombret@sls.aphp.fr | |
Principal Investigator: Hervé DOMBRET, Professor | |
Sub-Investigator: Emmanuel RAFFOUX, MD | |
CHU Brabois | Recruiting |
Vandoeuvre, France, 54511 | |
Contact: Agnes GUERCI-BRESLER, MD 0033383153281 a.guerci@chu-nancy.fr | |
Principal Investigator: GUERCI-BRESLER, MD | |
Hopital Hotel Dieu | Recruiting |
Nantes, France, 44093 | |
Contact: Jean-Luc HAROUSSEAU 0033240083271 jean-luc.harousseau@univ-nantes.fr | |
Principal Investigator: HAROUSSEAU, Professor | |
Hopital Archet | Recruiting |
Nice, France, 06202 | |
Contact: Laurence LEGROS, MD 0033492035844 legros.l@chu-nice.fr | |
Principal Investigator: LEGROS, MD | |
Hopital Cochin | Recruiting |
Paris, France, 75679 | |
Contact: Francois DREYFUS, Professor 003358412120 francois.dreyfus@cch.aphp.fr | |
Principal Investigator: DREYFUS, Professor | |
Hopital Saint Antoine | Not yet recruiting |
Paris, France, 75571 | |
Contact: Francoise isnard, MD 00033149282622 francoise.isnard@sat.aphp.fr | |
Principal Investigator: ISNARD, MD | |
Sub-Investigator: FOUILLARD, MD | |
Sub-Investigator: LEMONNIER, MD | |
Sub-Investigator: LAPORTE, MD | |
Sub-Investigator: GARDERET, MD | |
Sub-Investigator: COPPO, MD | |
Sub-Investigator: GORIN, Professor | |
Hopital Jean-Bernard | Recruiting |
Poitiers, France, 86021 | |
Contact: Francois GUILHOT, Professor 0033549444201 f.guilhot@chu-poitiers.fr | |
Principal Investigator: GUILHOT, Profesor | |
Sub-Investigator: ROY, MD | |
CHRU de Reims | Not yet recruiting |
Reims, France, 51092 | |
Contact: Chantal HIMBERLIN, MD 003326783644 chimberlin@chu-reims.fr | |
Principal Investigator: HIMBERLIN, MD | |
CHU Pontchaillou | Recruiting |
Rennes, France, 35033 | |
Contact: Martine ESCOFFRE-BARBE 0033299284291 martine.escoffre-barbe@chu-rennes.fr | |
Principal Investigator: ESCOFFRE-BARBE, MD | |
Sub-Investigator: DAURIAC, MD | |
Sub-Investigator: BERNARD, MD | |
Sub-Investigator: LAMY, MD | |
Sub-Investigator: NIMUBONA, MD | |
Hopital Hautepierre | Recruiting |
Strasbourg, France, 67098 | |
Contact: Shanti AME, MD 0033388127680 shanti.ame@chru-strasbourg.fr | |
Principal Investigator: AME, MD | |
Hopital Purpan | Recruiting |
Toulouse, France, 31031 | |
Contact: Guy LAURENT, Professor 0033561772078 laurent.g@chu-toulouse.fr | |
Principal Investigator: LAURENT, Professor | |
Principal Investigator: Odyle Beyne-Rauzy, MD | |
Sub-Investigator: Christian RECHER, MD | |
CH Versailles | Recruiting |
Versailles, France, 78000 | |
Contact: Sylvie CASTAIGNE, MD 0033139638909 scastaigne@ch-versailles.fr | |
Principal Investigator: CASTAIGNE, Professor | |
Sub-Investigator: Anne Laure TAKSIN, MD | |
Sub-Investigator: Philippe ROUSSELOT, MD | |
Hopital Paoli Calmette | Recruiting |
Marseille, France, 13273 | |
Contact: Norbert VEY, MD 0033431223695 veyn@marseille.fnclcc.fr | |
Principal Investigator: VEY, MD | |
Sub-Investigator: CHARBONNIER, MD | |
Sub-Investigator: GASTAUT, Professor | |
Sub-Investigator: BOUABDALLAH, MD | |
Sub-Investigator: REY, MD | |
Sub-Investigator: STOPPA, MD |
Principal Investigator: | Claude GARDIN, MD | Groupe Francophone des Myelodysplasies |
Study ID Numbers: | GFM aza05 |
Study First Received: | March 9, 2007 |
Last Updated: | March 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00446303 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
MDS Myelodysplastic Syndromes AML |
Intensive chemotherapy azacitidine AML |
Myelodysplastic syndromes Leukemia Preleukemia Precancerous Conditions Hematologic Diseases Myelodysplasia |
Myelodysplastic Syndromes Azacitidine Leukemia, Myeloid Bone Marrow Diseases Leukemia, Myeloid, Acute |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Pathologic Processes Disease Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Syndrome Enzyme Inhibitors Pharmacologic Actions |