Spots Global Cancer Trial Database for Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Hodgkin Lymphoma.
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Trial Identification
Brief Title: Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Hodgkin Lymphoma.
Official Title: Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Stage I/II Unfavourable Hodgkin Lymphoma. A Randomized Phase II LYSA-FIL-EORTC Intergroup Study
Study ID: NCT02292979
Conditions
Study Description
Brief Summary: This study aims to evaluate the efficacy of brentuximab vedotin + AVD combination (doxorubicine, vinblastine, dacarbazine) in patients with Hodgkin lymphoma stage I / II with an unfavorable diagnosis, assessed by the negativity of PET (positron emission tomography ) after two cycles of chemotherapy.
Detailed Description: Patients will receive either ABVD chemotherapy (standard treatment = doxorubicin, bleomycin, vinblastine, dacarbazine) or the Brentuximab vedotin in combination with chemotherapy AVD (study treatment), depending on randomization. Radiotherapy is planned after chemotherapy or immunochemotherapy. PET scans will be performed before inclusion, after 2 cycles of chemotherapy and after 4 cycles of chemotherapy (if PET after two cycles was positive), at the end of treatment and during follow-up period.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Locations
ZNA Middelheim, Antwerpen, , Belgium
ZNA Stuivenberg, Antwerpen, , Belgium
A.Z. Sint Jan AV, Brugge, , Belgium
Institut Jules Bordet, Bruxelles, , Belgium
UCL Louvain Saint Luc, Bruxelles, , Belgium
Grand Hôpital de Charleroi, Charleroi, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
U.Z. Leuven - Campus Gasthuisberg, Leuven, , Belgium
CHU de Liege, Liege, , Belgium
AZ Delta - Campus H. Hartziekenhuis, Roeselare, , Belgium
CHU Dinant Godinne, Yvoir, , Belgium
University Hospital Rebro, Zagreb, , Croatia
Rigshospitalet, Copenhagen, , Denmark
CHU d'Amiens, Amiens, , France
CHU d'Angers, Angers, , France
CH de Annecy, Annecy, , France
CHU Jean Minjoz, Besançon, , France
CH de Bourg en Bresse, Bourg en Bresse, , France
Centre François Baclesse, Caen, , France
CHU de Caen, Caen, , France
CH de Chalon sur Saône, Chalon sur Saône, , France
CH de Chambéry, Chambéry, , France
Hôpital Antoine Béclère, Clamart, , France
CHU de Clermont-Ferrand, Clermont-Ferrand, , France
CH Sud Francilien de Corbeil, Corbeil Essonnes, , France
CHU Henri Mondor, Créteil, , France
CHU de Dijon, Dijon, , France
CHU de Grenoble, Grenoble, , France
CH La Rochelle, La Rochelle, , France
Centre Hospitalier de Versailles - André Mignot, Le Chesnay, , France
CHRU de Lille - Hôpital Claude Hurriez, Lille, , France
CHU de Limoges, Limoges, , France
Centre Léon Bérard, Lyon, , France
Institut Paoli Calmettes, Marseille, , France
CH de Meaux, Meaux, , France
CHR de Metz, Metz, , France
CHU de Montpellier - Saint Eloi, Montpellier, , France
CHU de Mulhouse, Mulhouse, , France
CHU Nancy Brabois, Nancy, , France
CHU Hôtel Dieu Nantes, Nantes, , France
CHU de Nîmes, Nîmes, , France
Hôpital Necker, Paris, , France
Hôpital de la Pitié Salpétrière, Paris, , France
Hôpital Saint Antoine, Paris, , France
Hôpital Saint Louis, Paris, , France
Centre François Magendie, Pessac, , France
Centre Hospitalier Lyon Sud, Pierre Bénite, , France
CHU Robert Debré, Reims, , France
CHU Pontchaillou, Rennes, , France
CH de Roubaix, Roubaix, , France
Centre Henri Becquerel, Rouen, , France
Institut de Cancérologie de Loire, Saint Priest en Jarez, , France
CHU de Strasbourg, Strasbourg, , France
CHU de Toulouse, Toulouse, , France
CHU Bretonneau, Tours, , France
Institut Gustave Roussy, Villejuif, , France
Academisch Medisch Centrum - Universiteit van Amsterdam, Amsterdam, , Netherlands
Antoni Van Leeuwenhoekziekenhuis, Amsterdam, , Netherlands
Amphia Ziekenhuis, Breda, , Netherlands
Reinier De Graaf Gasthuis, Delft, , Netherlands
University Medical Center Groningen, Groningen, , Netherlands
Leiden University Medical Centre, Leiden, , Netherlands
Radboud University Medical Center Nijmegen, Nijmegen, , Netherlands
Erasmus MC Cancer Institute - location Daniel den Hoed, Rotterdam, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Contact Details
Name: Marc André, Pr
Affiliation: Lymphoma Study Association
Role: PRINCIPAL_INVESTIGATOR
Name: Luc Fornecker, Dr
Affiliation: Lymphoma Study Association
Role: PRINCIPAL_INVESTIGATOR
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