A Study of MabThera (Rituximab) in Patients With Advanced Non-Hodgkin's Lymphoma - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 22, 2005

Last Updated Date

April 15, 2009

Start Date ^†

Current Primary Outcome Measures ^†

Clinical response (complete or partial remission). [ Time Frame: After 8 months of treatment ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Remission rate (rate of complete and partial remissions)

Change History

Complete list of historical versions of study NCT00269113 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Adverse drug effects, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Non-Hodgkin's Lymphoma

Intervention ^†

Drug: rituximab [MabThera/Rituxan]
Drug: Standard chemotherapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

368

Completion Date

April 2009

Primary Completion Date

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.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Germany

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00269113

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Secondary IDs ^††

Study Sponsor ^†

Hoffmann-La Roche

Collaborators ^††

Investigators ^†

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.