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

NCT ID: NCT00269113

Last Updated: 2015-07-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-09-30

Study Completion Date

2009-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Hodgkin's Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

rituximab [MabThera/Rituxan]

Intervention Type DRUG

375mg/m2 iv monthly for 8 cycles

Standard chemotherapy

Intervention Type DRUG

As prescribed

2

Group Type ACTIVE_COMPARATOR

Standard chemotherapy

Intervention Type DRUG

As prescribed

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

rituximab [MabThera/Rituxan]

375mg/m2 iv monthly for 8 cycles

Intervention Type DRUG

Standard chemotherapy

As prescribed

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Berlin, , Germany

Site Status

Berlin, , Germany

Site Status

Bochum, , Germany

Site Status

Bonn, , Germany

Site Status

Borna, , Germany

Site Status

Chemnitz, , Germany

Site Status

Cottbus, , Germany

Site Status

Dresden, , Germany

Site Status

Dresden, , Germany

Site Status

Dülmen, , Germany

Site Status

Erfurt, , Germany

Site Status

Frankfurt (Oder), , Germany

Site Status

Greifswald, , Germany

Site Status

Güstrow, , Germany

Site Status

Halle, , Germany

Site Status

Halle, , Germany

Site Status

Jena, , Germany

Site Status

Jena, , Germany

Site Status

Leipzig, , Germany

Site Status

Leipzig, , Germany

Site Status

Magdeburg, , Germany

Site Status

Magdeburg, , Germany

Site Status

Marburg, , Germany

Site Status

Neubrandenburg, , Germany

Site Status

Nordhausen, , Germany

Site Status

Potsdam, , Germany

Site Status

Riesa, , Germany

Site Status

Rostock, , Germany

Site Status

Rostock, , Germany

Site Status

Schwerin, , Germany

Site Status

Stralsund, , Germany

Site Status

Trier, , Germany

Site Status

Zella-Mehlis, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M39023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Primary Rituximab and Maintenance
NCT00140582 COMPLETED PHASE3