Trial information
A Study of MabThera (Rituximab) in Combination With a Chemotherapy Regimen for the Treatment of Chronic Lymphocytic Leukemia.
Status: No longer recruiting
Protocol number: ML17102
Sponsor: F Hoffman-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of MabThera, with and without fludarabine/cyclophosphamide, on progression-free survival in patients with chronic lymphocytic leukemia
Brief summary: This study will assess the efficacy and safety of adding MabThera to chemotherapy in patients with previously untreated B-cell chronic lymphocytic leukemia (B-CLL). The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Target sample size is 760.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Lymphocytic Leukemia, Chronic
Intervention type: Drug
Intervention name: rituximab[MabThera/Rituxan]
Primary outcome: 1. Progression-free survival
Key secondary outcomes: 1. Event-free survival; overall survival; disease-free survival; duration of remission; time to new CLL treatment or death; rates of molecular, complete, and partial remission; treatment-related adverse events; pharmacoeconomic impact; QOL
Inclusion criteria:
- adult patients >=18 years of age;
- confirmed B-CLL;
- no previous chemotherapy, radiotherapy, or immunotherapy for the treatment of CLL;
- women of childbearing potential must have a negative serum pregnancy test 7 days prior to treatment, and must be prepared to use reliable contraception for the duration of treatment, and for 2 months after the end of treatment.
Exclusion criteria:
- women who are pregnant or lactating;
- active secondary malignancy currently requiring treatment;
- transformation to aggressive B-cell malignancy.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2003
Trial registration date: 06/24/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Brisbane
- Frankston
- Fremantle
- Geelong
- Gosford
- Melbourne
- Newcastle
- Perth
- St. Leonards
- Sydney
- Woolloongabba
Austria
Belgium
- Brugge
- Bruxelles
- Edegem
- Leuven
- Mont-Godinne
Czech Republic
- Brno
- Hradec Kralove
- Olomouc
- Plzen
- Praha
Denmark
France
- Bordeaux
- Colmar
- Le Chesnay
- Le Mans
- Lille
- Limoges
- Lyon
- Marseille
- Montpellier
- Paris
- Rennes
- Saint-Priest-En-Jarez
- Strasbourg
- Toulouse
Germany
- Ahaus
- Ansbach
- Augsburg
- Bad Saarow
- Bayreuth
- Berlin
- Bielefeld
- Bietigheim-Bissingen
- Bochum
- Bottrop
- Bremen
- Burglengenfeld
- Coesfeld
- Cottbus
- Dresden
- Düsseldorf
- Eisenach
- Erfurt
- Erlangen
- Eschweiler
- Essen
- Esslingen
- Forchheim
- Frankfurt Am Main
- Frankfurt An Der Oder
- Freiburg
- Garmisch-Partenkirchen
- Gerlingen
- Giessen
- Göttingen
- Greifswald
- Hagen
- Halle
- Hamburg
- Hamm
- Hannover
- Heidelberg
- Herne
- Herrsching
- Homburg
- Idar-Oberstein
- Jena
- Karlsruhe
- Kassel
- Kempten
- Kiel
- Koblenz
- Köln
- Kronach
- Landshut
- Leer
- Leipzig
- Lemgo
- Lörrach
- Lübeck
- Ludwigshafen
- Magdeburg
- Mainz
- Mannheim
- Munchen
- München
- Münchengladbach
- Münster
- Neunkirchen
- Nordenstedt
- Nürnberg
- Oberhausen
- Offenbach
- Oldenburg
- Pasewalk
- Pforzheim
- Potsdam
- Recklinghausen
- Regensburg
- Rostock
- Saarbrücken
- Sande
- Siegen
- Stuttgart
- Torgau
- Trier
- Troisdorf
- Tübingen
- Ulm
- Villingen-Schwenningen
- Wanzleben
- Weiden
- Wesel
- Wiesbaden
- Wuerzburg
- Wuppertal
- Würzburg
Israel
- Beer Sheva
- Haifa
- Jerusalem
- Kfar Saba
- Ramat Gan
- Rehovot
Italy
- Bologna
- Cagliari
- Genova
- Milano
- Roma
- Siena
- Torino
- Verona
- Vicenza
New Zealand
- Auckland
- Christchurch
- Palmerston North
Spain
- Madrid
- Malaga
- Murcia
- Toledo
