Spots Global Cancer Trial Database for A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia
Official Title: An Adaptive, Comparative, Randomized, Parallel-group, Multi Center, Phase Ib Study of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With Chemotherapy (Fludarabine and Cyclophosphamide), in Patients With Previously Untreated CLL
Study ID: NCT01292603
Conditions
Study Description
Brief Summary: This randomized, parallel-group, multi-center study will compare the pharmacokinetics and safety of subcutaneous administration of MabThera (rituximab) versus intravenous MabThera in combination with chemotherapy in previously untreated patients with chronic lymphocytic leukemia (CLL). The study consists of 2 parts. In part 1, patients who have previously received 4 cycles of intravenous MabThera will receive in Cycle 5 intravenous MabThera and in Cycle 6 subcutaneous MabThera. In part 2, patients will be randomized to receive either 6 cycles of intravenous MabThera, or 1 cycle of intravenous MabThera and 5 cycles of subcutaneous MabThera. Additionally, all patients will receive chemotherapy (fludarabine and cyclophosphamide) on Days 1-3 or Days 1-5 of every cycle. The anticipated time on study drug is 24 weeks.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Fundaleu; Haematology, Buenos Aires, , Argentina
Cemic; Haematology, Buenos Aires, , Argentina
HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología, Córdoba, , Argentina
St George Hospital; Department of Haematology, Kogarah, New South Wales, Australia
Royal Brisbane and Women'S Hospital; Haematology, Herston, Queensland, Australia
Ashford Cancer Center Research, Kurralta Park, South Australia, Australia
Queen Elizabeth Hospital; Haematology, Woodville South, South Australia, Australia
St Vincent'S Hospital; Haematology, Fitzroy, Victoria, Australia
Frankston Hospital; Oncology/Haematology, Frankston, Victoria, Australia
Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia, Passo Fundo, RS, Brazil
Hospital Mae de Deus, Porto Alegre, RS, Brazil
Hospital Sirio Libanes; Centro de Oncologia, Sao Paulo, SP, Brazil
Hospital das Clinicas - FMUSP, Sao Paulo, SP, Brazil
Queen Elizabeth II Health Sciences Centre; Oncology, Halifax, Nova Scotia, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal, Quebec, Canada
Centre de sante et de services sociaux Rimouski Neigette, Rimouski, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
Instituto Nacional del Cancer, Santiago, , Chile
Centro Internacional de Estudios Clínicos (CIEC), Santiago, , Chile
Clinical Hospital Merkur; Dept of Haematology, Zagreb, , Croatia
University Hospital Center Zagreb; Haematology Department, Zagreb, , Croatia
Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika, Brno, , Czechia
University Hospital and Medical School; IV.Dept. of Internal Medicine and Hematology, Hradec Kralove, , Czechia
Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK, Praha 2, , Czechia
Centre Francois Baclesse, Caen, , France
Institut J Paolii Calmettes; Onco Hematologie 1, Marseille, , France
Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset), Paris, , France
Hopital Robert Debre; Hematologie Clinique, Reims, , France
Hopitaux De Brabois; Hematologie Medecine Interne, Vandoeuvre Les Nancy, , France
Onkologische Schwerpunktpraxis Kurfürstendamm, Berlin, , Germany
Onkologischer Schwerpunkt am Oskar-Helene-Heim; Dres. Herrenberger, Keitel-Wittig u. Kirsch, Berlin, , Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie, Dresden, , Germany
Klinikum Frankfurt; Medizinische Klinik I, Frankfurt an der Oder, , Germany
Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik, Greifswald, , Germany
Onkologische Schwerpunktpraxis Dres. Bernd Gaede, Hans-Ulrich Ehlers, Ulrike Rodewig u.w., Hannover, , Germany
Gemeinschaftspraxis Dr. Siehl & Dr. Soeling, Kassel, , Germany
Klinik der Uni zu Köln; Klinik für Innere Medizin, Köln, , Germany
K&K Studien GbR, Landshut, , Germany
Onkologische Schwerpunktpraxis Lübeck, Lübeck, , Germany
Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach, Marburg, , Germany
Klinikum Grosshadern der LMU, Muenchen, , Germany
Medizinisches Versorgungszentrum MOP, München, , Germany
Gemeinschaftspraxis Dr. med. Holger Klaproth / Dr. med. Anca Astrid Cura, Neunkirchen/Saar, , Germany
Prosper-Hospital, Medizinische Klinik I, Recklinghausen, , Germany
Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine, Athens, , Greece
Papageorgiou General Hospital of Thessaloniki; Hematology Clinic, Thessaloniki, , Greece
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica, Meldola, Emilia-Romagna, Italy
Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia, Ravenna, Emilia-Romagna, Italy
Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia, Rimini, Emilia-Romagna, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica, Udine, Friuli-Venezia Giulia, Italy
Istituto S. Raffaele Monte Tabor; Divisione Ematologia E Utmo, Milano, Lombardia, Italy
ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia, Milano, Lombardia, Italy
Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad, Novara, Piemonte, Italy
Policlinico G. B. Rossi; Divisione Di Ematologia, Verona, Veneto, Italy
Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre, Chihuahua, , Mexico
Hospital General De Culiacan; Servicio De Hematologia, Culiacan, , Mexico
Hospital Universitario Dr. Jose E. Gonzalez; Haematology, Monterrey, , Mexico
Canterbury Health Laboratories; Haematology, Christchurch, , New Zealand
Wellington Hospital; Wellington Blood and Cancer Centre, Newtown, , New Zealand
Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii, Gdansk, , Poland
Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie, Lublin, , Poland
Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Lymphoma Dept., Warszawa, , Poland
Medical Uni of Wroclaw; Hematology, Wroclaw, , Poland
Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula, Lisboa, , Portugal
IPO do Porto; Servico de Onco-Hematologia, Porto, , Portugal
N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis, Moscow, , Russian Federation
City Clinical Hospital After Botkin; Hematology, Moscow, , Russian Federation
Haematology Research Center; Haematology, Moscow, , Russian Federation
Penza Regional Oncology Dispensary, Penza, , Russian Federation
Clinical MSCh No1, Perm, , Russian Federation
St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta, Saint-Petersburg, , Russian Federation
National Oncology Inst. ; Dept. of Haematology, Bratislava, , Slovakia
University Hospital; Clinic of Hematology & Transfusiology, Bratislava, , Slovakia
Hospital Universitari Vall d'Hebron; Servicio de Hematologia, Barcelona, , Spain
Hospital Universitario de la Princesa; Servicio de Hematologia, Madrid, , Spain
Hospital Universitario Puerta de Hierro; Servicio de Hematologia, Madrid, , Spain
Hospital Clinico Universitario de Salamanca;Servicio de Hematologia, Salamanca, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Hematologia, Sevilla, , Spain
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Hematología, Toledo, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
Hacettepe Uni Medical Faculty; Hematology, Ankara, , Turkey
Istanbul University Cerrahpasa Medical Faculty; Hematology Department, Istanbul, , Turkey
Dokuz Eylul Uni ; Hematology, Izmir, , Turkey
Ege University ARGEFAR, Izmir, , Turkey
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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