Trial information
A Study of MabThera (Rituximab) in Patients With Advanced Non-Hodgkin's Lymphoma
Status: No longer recruiting
Protocol number: M39023
Sponsor: Hoffmann-La Roche AG
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of MabThera plus chemotherapy versus chemotherapy alone on clinical response in patients with indolent non-Hodgkin's and mantle cell lymphoma
Brief summary: This 2 arm study will compare the efficacy and safety of the standard chemotherapy of the East German Study Group for Hematology and Oncology versus standard chemotherapy plus MabThera (375mg/m2 iv, once monthly for 8 cycles) in patients with indolent non-Hodgkin's and mantle cell lymphoma. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Target sample size is 376.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Non-Hodgkin's Lymphoma
Intervention type: Drug
Intervention name: rituximab [MabThera/Rituxan]
Primary outcome: 1. Clinical response (complete or partial remission). Time frame: After 8 months of treatment
2. Duration of response Time frame: Event driven
Key secondary outcomes: 1. Adverse drug effects, laboratory parameters, vital signs Time frame: Throughout study
Inclusion criteria:
- adult patients >=18 years of age;
- advanced, low-grade non-Hodgkin's and mantle cell lymphoma.
Exclusion criteria:
- possibility of curative radiation therapy;
- secondary NHL;
- participation in another clinical trial eg with cytostatic chemotherapy or cytokines;
- concomitant diseases and/or restricted organ function precluding therapy according to the study protocol.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: September, 1998
Trial registration date: 08/29/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Germany
- Berlin
- Bochum
- Bonn
- Borna
- Chemnitz
- Cottbus
- Dresden
- Dülmen
- Erfurt
- Frankfurt An Der Oder
- Greifswald
- Güstrow
- Halle
- Jena
- Leipzig
- Magdeburg
- Marburg
- Neubrandenburg
- Nordhausen
- Potsdam
- Riesa
- Rostock
- Schwerin
- Stralsund
- Trier
- Zella-Mehlis
