A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia
NCT ID: NCT01292603
Last Updated: 2018-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
240 participants
INTERVENTIONAL
2011-04-18
2017-11-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
NONE
Study Groups
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1
Cyclophosphamide
Days 1-3 or Days 1-5 of cycles 1-6
Fludarabine
Days 1-3 or Days 1-5 of cycles 1-6
rituximab [MabThera]
After 4 cycles of intravenous MabThera without experiencing grade 3 or 4 infusion-related reactions. patients will receive 1 additional cycle of intravenous MabThera and 1 cycle of subcutaneous MabThera.
2
Cyclophosphamide
Days 1-3 or Days 1-5 of cycles 1-6
Fludarabine
Days 1-3 or Days 1-5 of cycles 1-6
rituximab [MabThera]
6 cycles of intravenous MabThera
3
Cyclophosphamide
Days 1-3 or Days 1-5 of cycles 1-6
Fludarabine
Days 1-3 or Days 1-5 of cycles 1-6
rituximab [MabThera]
One cycle of intravenous MabThera, followed by 5 cycles of subcutaneous MabThera
Interventions
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Cyclophosphamide
Days 1-3 or Days 1-5 of cycles 1-6
Fludarabine
Days 1-3 or Days 1-5 of cycles 1-6
rituximab [MabThera]
One cycle of intravenous MabThera, followed by 5 cycles of subcutaneous MabThera
rituximab [MabThera]
After 4 cycles of intravenous MabThera without experiencing grade 3 or 4 infusion-related reactions. patients will receive 1 additional cycle of intravenous MabThera and 1 cycle of subcutaneous MabThera.
rituximab [MabThera]
6 cycles of intravenous MabThera
Eligibility Criteria
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Inclusion Criteria
* Patients with treatment-requiring chronic lymphocytic leukemia (CLL)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Life expectancy \>6 months
Exclusion Criteria
* History of other malignancy unless the patient was treated with curative intent and has been in remission for more than 5 years prior to enrolment
* HIV or Hepatitis B positive unless clearly due to vaccination
* Inadequate liver or renal function
* Any coexisting medical or psychological condition that would preclude participation in the required study procedures
Additional exclusion criterion for Part 1:
* Any previous treatment for CLL except for up to 4 cycles of rituximab IV in combination with FC chemotherapy as first-line treatment for CLL
Additional exclusion criterion for Part 2:
* Any previous treatment for CLL
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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, Rio Grande do Sul, Brazil
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sirio Libanes; Centro de Oncologia
São Paulo, São Paulo, Brazil
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, 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 Králové, , Czechia
Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK
Prague, , 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
Vandœuvre-lès-Nancy, , France
Onkologische Schwerpunktpraxis Kurfürstendamm
Berlin, , Germany
Onkologischer Schwerpunkt am Oskar-Helene-Heim; Dres. Herrenberger, Keitel-Wittig u. Kirsch
Berlin, , Germany
Klinik der Uni zu Köln; Klinik für Innere Medizin
Cologne, , Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, , Germany
Klinikum Frankfurt; Medizinische Klinik I
Frankfurt (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.
Hanover, , Germany
Gemeinschaftspraxis Dr. Siehl & Dr. Soeling
Kassel, , Germany
K&K Studien GbR
Landshut, , Germany
Onkologische Schwerpunktpraxis Lübeck
Lübeck, , Germany
Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach
Marburg, , Germany
Medizinisches Versorgungszentrum MOP
München, , Germany
Klinikum Grosshadern der LMU
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
Milan, Lombardy, Italy
ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia
Milan, Lombardy, Italy
Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad
Novara, Piedmont, Italy
Policlinico G. B. Rossi; Divisione Di Ematologia
Verona, Veneto, Italy
Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre
Chihuahua City, , Mexico
Hospital General De Culiacan; Servicio De Hematologia
Culiacán, , 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.
Warsaw, , Poland
Medical Uni of Wroclaw; Hematology
Wroclaw, , Poland
Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula
Lisbon, , Portugal
IPO do Porto; Servico de Onco-Hematologia
Porto, , Portugal
N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
Moscow, , Russia
City Clinical Hospital After Botkin; Hematology
Moscow, , Russia
Haematology Research Center; Haematology
Moscow, , Russia
Penza Regional Oncology Dispensary
Penza, , Russia
Clinical MSCh No1
Perm, , Russia
St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta
Saint Petersburg, , Russia
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
Seville, , 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 (Türkiye)
Istanbul University Cerrahpasa Medical Faculty; Hematology Department
Istanbul, , Turkey (Türkiye)
Dokuz Eylul Uni ; Hematology
Izmir, , Turkey (Türkiye)
Ege University ARGEFAR
Izmir, , Turkey (Türkiye)
Countries
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References
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Assouline S, Buccheri V, Delmer A, Gaidano G, Trneny M, Berthillon N, Brewster M, Catalani O, Li S, McIntyre C, Sayyed P, Badoux X. Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non-inferiority trial. Lancet Haematol. 2016 Mar;3(3):e128-38. doi: 10.1016/S2352-3026(16)00004-1.
Assouline S, Buccheri V, Delmer A, Gaidano G, McIntyre C, Brewster M, Catalani O, Hourcade-Potelleret F, Sayyed P, Badoux X. Pharmacokinetics and safety of subcutaneous rituximab plus fludarabine and cyclophosphamide for patients with chronic lymphocytic leukaemia. Br J Clin Pharmacol. 2015 Nov;80(5):1001-9. doi: 10.1111/bcp.12662. Epub 2015 Jul 29.
Mao CP, Brovarney MR, Dabbagh K, Birnbock HF, Richter WF, Del Nagro CJ. Subcutaneous versus intravenous administration of rituximab: pharmacokinetics, CD20 target coverage and B-cell depletion in cynomolgus monkeys. PLoS One. 2013 Nov 12;8(11):e80533. doi: 10.1371/journal.pone.0080533. eCollection 2013.
Shpilberg O, Jackisch C. Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase. Br J Cancer. 2013 Sep 17;109(6):1556-61. doi: 10.1038/bjc.2013.371. Epub 2013 Sep 3.
Other Identifiers
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2010-021380-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BO25341
Identifier Type: -
Identifier Source: org_study_id