Spots Global Cancer Trial Database for Evaluation of Efficacy and Safety of Nilotinib in Combination With Chemotherapy in Elderly Patients With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
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Trial Identification
Brief Title: Evaluation of Efficacy and Safety of Nilotinib in Combination With Chemotherapy in Elderly Patients With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Official Title: An Open Label Phase II Study to Evaluate the Efficacy and Safety of Induction and Consolidation Therapy With Nilotinib in Combination With Chemotherapy in Patients Aged 55 Years and Over With Philadelphia Chromosome Positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukemia (ALL)
Study ID: NCT01528085
Interventions
Study Description
Brief Summary: The goal of this trial is to evaluate the efficacy and the tolerance of the combination of nilotinib with chemotherapy in the front-line setting as induction and consolidation therapy in Ph+ ALL patient aged 55 years and over. A European consensus has been reached to adopt a common chemotherapeutic schedule for patients aged 55 years and over. This schedule will be used in this trial with the addition of nilotinib as concomitant therapy during induction, consolidation and maintenance. The patients will be prospectively monitored for minimal residual disease and bcr-abl tyrosine kinase domain mutations.
Detailed Description:
Eligibility
Minimum Age: 55 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Centre Hospitalier du Pays d'Aix, Aix-en-Provence cedex 1, , France
CHU d'Amiens - Hôpital Sud, AMIENS Cedex 1, , France
Chu Angers, ANGERS Cedex 09, , France
Centre Hospitalier Victor Dupouy, Argenteuil Cedex, , France
Centre Hospitalier de la Côte Basque, Bayonne, , France
CHU de Besançon - Hôpital Jean Minjoz, BESANÇON Cedex, , France
CHU de Brest - Hôpital Morvan, BREST Cedex, , France
"CHU Cote de nacre ", Caen, , France
CHU Estaing, Clermont Ferrand, , France
AP-HP - Hôpital Henri Mondor, Creteil, , France
CHRU de Dijon, DIJON Cedex, , France
CHU de Grenoble, Grenoble cedex 9, , France
CH de Versailles - Hôpital André Mignot, LE CHESNAY Cedex, , France
Groupe Hospitalier de l'Institut Catholique de Lille, hôpital Saint-Vincent, Lille Cedex, , France
CHRU de Lille, LILLE Cedex, , France
C H U de Limoges - Hôpital Dupuytren, LIMOGES Cedex, , France
Institut Paoli-Calmettes, Marseille cedex 9, , France
CH de Meaux, MEAUX Cedex, , France
Hôpital Saint-Eloi, MONTPELLIER Cedex 5, , France
CH de Mulhouse - Hôpital Emile Muller, MULHOUSE Cedex, , France
CHU Hôtel Dieu, Nantes, Nantes, , France
CHU de Nice - Hôpital l'Archet 1, Nice, , France
CHR d'Orléans - Hôpital La Source, ORLEANS Cedex, , France
AP-HP - Hôpital Saint Louis, PARIS Cedex 10, , France
AP-HP - Hôpital SAINT-ANTOINE, PARIS cedex 12, , France
AP-HP - Hôpital Necker, PARIS Cedex 15, , France
CH de Perpignan - Hôpital Saint-Jean, PERPIGNAN cedex 09, , France
CHU de Bordeaux - Hôpital Haut-Lévêque, PESSAC Cedex, , France
Centre Hospitalier Lyon Sud, Pierre-Bénite Cedex, , France
CHU de Poitiers - Hôpital La Milétrie, POITIERS Cedex, , France
CH de la Région d'Annecy, Pringy Cedex, , France
CHU de Reims - Hôpital Robert Debré, REIMS Cedex, , France
CHU de Rennes, Hôpital Pontchaillou, RENNES Cedex 9, , France
Centre Henri Becquerel, Rouen, Rouen Cedex 1, , France
CHU de La Réunion - Hôpital Félix Guyon, SAINT DENIS Cedex, , France
CHRU de Strasbourg - Hôpital Hautepierre, STRASBOURG Cedex, , France
HIA Sainte Anne, TOULON Cedex 9, , France
"Institut Universitaire du Cancer (CHU de Toulouse - Hôpital Purpan)", Toulouse, , France
CHRU de Tours - Hôpital Bretonneau, TOURS Cedex 9, , France
Centre Hospitalier de Valenciennes, VALENCIENNES Cedex, , France
CHU de Nancy - Hôpital Brabois, Vandoeuvre Les Nancy, , France
Robert Bosch Krankenhaus, Stuttgart, Baden-Württemberg, Germany
Klinikum der Universität Regensburg, Regensburg, Bayern, Germany
University Hospital of Frankfurt, Medical Dept. II, Frankfurt, Hessen, Germany
Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany
Universitätsklinikum Essen, Essen, NRW, Germany
Universitätsklinik Münster, Münster, NRW, Germany
Universitätsklinik Dresden, Dresden, Sachsen, Germany
Uniklinik Aachen, Aachen, , Germany
Charité Universitätsmedizin Berlin, Berlin, , Germany
University Hospital Düsseldorf, Düsseldorf, , Germany
Universitätsklinikum Göttingen, Göttingen, , Germany
Asklepios Klinik St. Georg, Hamburg, , Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel, Kiel, , Germany
Universität Leipzig, José-Carreras-Haus, Leipzig, , Germany
Universitätskliniken Mainz, Mainz, , Germany
Klinikum Mannheim, Mannheim, , Germany
Universitätsklinikum Großhadern, München, , Germany
Klinikum Nürnberg Nord, Nürnberg, , Germany
Klinikum Oldenburg, Oldenburg, , Germany
Universität Rostock, Rostock, , Germany
Medizinische Universitätsklinik Ulm, Ulm, , Germany
Universität Würzburg, Würzburg, , Germany
Hospital Clínic de Barcelona, Barcelona, , Spain
Hospital Universitario Germans Trias i Pujol (ICO - Badalona), Barcelona, , Spain
Hospital Universitario 12 de Octubre (Madrid), Madrid, , Spain
Hospital Clínico Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen del Rocío (Sevilla), Sevilla, , Spain
Hospital Universitario y Politécnico La Fe (Valencia), Valencia, , Spain
Contact Details
Name: Heike Pfeifer, Dr.med.
Affiliation: Johann Wolfgang Goethe University Hospital
Role: PRINCIPAL_INVESTIGATOR
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