Spots Global Cancer Trial Database for Alemtuzumab and CHOP in T-cell Lymphoma
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Trial Identification
Brief Title: Alemtuzumab and CHOP in T-cell Lymphoma
Official Title: A Randomized Phase III Study to Evaluate the Efficacy of Chemoimmunotherapy With the Monoclonal Antibody Campath-1H (Alemtuzumab) Given in Combination With 2-weekly CHOP Versus 2-weekly CHOP Alone and Consolidated by Autologous Stem Cell Transplant, in Young Patients With Previously Untreated Systemic Peripheral T-cell Lymphomas
Study ID: NCT00646854
Conditions
Study Description
Brief Summary: The purpose of this study is to determine efficacy and safety of the monoclonal antibody MabCampath® (alemtuzumab) combined with chemotherapy in the treatment of T-cell lymphoma.
Detailed Description: First International phase III T-cell lymphoma study Indication:Newly diagnosed non-cutaneous peripheral T-cell lymphoma Study objectives:Determination of the efficacy and safety of the monoclonal antibody MabCampath® (alemtuzumab) combined with two-weekly CHOP supported by G-CSF Primary Endpoint: Event-Free-Survival (EFS) Study Design: International open-label, multicentre, randomized Phase III Study Study Medication: Patients are randomized to six cycles of two-weekly CHOP plus G-CSF with or without alemtuzumab given subcutaneously 30 mg day 1 in combination with chemotherapy cycles 1-4. Patients in CR, CRu and PR after the 6 cycles of CHOP14 combined or not with alemtuzumab will receive a consolidation with high-dose chemotherapy followed by autologous stem cell transplantation. Patient Population: Patients \> 18 yrs with newly diagnosed non-cutaneous, non-leukemic PTCL, except alk-protein positive and negative anaplastic large cell lymphoma Planned Sample Size: 308 young patients (18-60 yrs) registered and randomized Total Number of Centers: This study will be proposed to main European and Australian Study Groups.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Locations
AKH Linz, Linz, , Austria
Krankenhaus der Elisabethinen, Linz, , Austria
Center for Clinical Cancer and Immunology Trials, Salzburg, , Austria
Hanusch Krankenhaus, Vienna, , Austria
ZNA Middelheim, Antwerpen, , Belgium
ZNA Stuivenberg, Antwerpen, , Belgium
AZ St Jan, Brugge, , Belgium
UZ VUB, Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Grand Hôpital de Charleroi, Charleroi, , Belgium
Hôpital de Jolimont, Haine-St-Paul, , Belgium
UZ Gasthuisberg, Leuven, , Belgium
CHR de la Citadelle, Liége, , Belgium
Clinique St Pierre, Ottignies, , Belgium
Heilig-Hartziekenhuis, Roeselare, , Belgium
Clinique de Mont-Godinne, Yvoir, , Belgium
University Hospital Brno, Brno, , Czechia
University Hospital Olomouc, Olomouc, , Czechia
University Hospital Ostrava, Ostrava, , Czechia
University Hospital Kralovske Vinohrady, Prague, , Czechia
University Hospital Motol, Prague, , Czechia
Aalborg Hospital, Aalborg, , Denmark
Aarhus University Hospital, Aarhus, , Denmark
Rigshospitalet, Copenhagen, , Denmark
Herlev Hospital, Herlev, , Denmark
Odense University Hospital, Odense, , Denmark
Vejle Hospital, Vejle, , Denmark
Helsinki University Central Hospital, Helsinki, , Finland
Kuopio University Hospital, Kuopio, , Finland
Oulu University Hospital, Oulu, , Finland
Tampere University Hospital, Tampere, , Finland
Turku University Central Hospital, Turku, , Finland
Charite Universitätsmedizin Berlin, Berlin, , Germany
Krankenhaus Nordwest, Frankfurt, , Germany
University Hospital Regensburg, Regensburg, , Germany
Meander Medical Center, Amersfoort, , Netherlands
Vrije University Medical Center, Amsterdam, , Netherlands
Academisch Medisch Centrum, Amsterdam, , Netherlands
Haga Ziekenhuis, loc. Leyenburg, Den Haag, , Netherlands
Medisch Spectrum Twente, Enschede, , Netherlands
University Medical Center Groningen, Groningen, , Netherlands
Leids University Medical Center, Leiden, , Netherlands
Academisch Ziekenhuis Maastricht, Maastricht, , Netherlands
Sint Antonius Ziekenhuis, Nieuwegein, , Netherlands
University Medical Center St. Radboud, Nijmegen, , Netherlands
Erasmus Medical Center - Centrum, Rotterdam, , Netherlands
Erasmus Medical Center Daniel, Rotterdam, , Netherlands
Isala Klinieken, Sophia, Zwolle, , Netherlands
Radium Hospital, Oslo, , Norway
Stavanger University Hospital, Stavanger, , Norway
University Hospital of Nothern Norway, Tromsoe, , Norway
St. Olavs Hospital, Trondheim, , Norway
Marie Sklodowska-Curie Memorial Institute Cancer Center, Warsaw, , Poland
IPO Lisboa, Lisbon, , Portugal
IPO Porto, Porto, , Portugal
Sunderby Hospital, Lulea, , Sweden
Lund University Hospital, Lund, , Sweden
Karolinska University Hospital, Stockholm, , Sweden
Norrlands University Hospital, Umea, , Sweden
Contact Details
Name: Francesco d'Amore, Prof
Affiliation: Dept. of Hematology, Århus University Hospital, Denmark
Role: PRINCIPAL_INVESTIGATOR
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