Clinical trial NCT00269113: A Study of MabThera (Rituximab) in Patients With Advanced Non-Hodgkin's Lymphoma
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2005-12-23
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving CR or PR at the End of Therapy
timeFrame: Following completion of 6 cycles (24 weeks)
Secondary outcomes:
measure: Progression-Free Survival (PFS) - Percentage of Participants Event Free at 24 Months
timeFrame: 24 months
measure: Overall Survival (OS) - Percentage of Participants Alive at 24 Months
timeFrame: Month 24
measure: Event-Free Survival (EFS) - Percentage of Participants Event Free at 24 Months
timeFrame: Month 24
measure: Disease-Free Survival (DFS) - Percentage of Participants Event Free at 24 Months
timeFrame: Month 24
measure: Response Duration - Percentage of Participants Event Free at 24 Months
timeFrame: Month 24
measure: Time to Next Treatment - Percentage of Participants Who Did Not Need New Treatment at 24 Months
timeFrame: Month 24
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Bonn
country: Germany
city: Borna
country: Germany
city: Chemnitz
country: Germany
city: Cottbus
country: Germany
city: Dresden
country: Germany
city: Dresden
country: Germany
city: Dülmen
country: Germany
city: Erfurt
country: Germany
city: Frankfurt An Der Oder
country: Germany
city: Greifswald
country: Germany
city: Güstrow
country: Germany
city: Halle (saale)
country: Germany
city: Halle
country: Germany
city: Halle
country: Germany
city: Jena
country: Germany
city: Jena
country: Germany
city: Leipzig
country: Germany
city: Leipzig
country: Germany
city: Magdeburg
country: Germany
city: Magdeburg
country: Germany
city: Marburg
country: Germany
city: Neubrandenburg
country: Germany
city: Nordhausen
country: Germany
city: Potsdam
country: Germany
city: Riesa
country: Germany
city: Rostock
country: Germany
city: Rostock
country: Germany
city: Schwerin
country: Germany
city: Stralsund
country: Germany
city: Trier
country: Germany
city: Zella-mehlis
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: