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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00269113

Purpose

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.

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma	Drug: rituximab [MabThera/Rituxan] Drug: Standard chemotherapy	Phase III

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Hoffmann-La Roche:

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 ]

Secondary Outcome Measures:

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

Estimated Enrollment:	376
Study Start Date:	September 1998
Estimated Study Completion Date:	June 2008

Arms	Assigned Interventions
1: Experimental	Drug: rituximab [MabThera/Rituxan] 375mg/m2 iv monthly for 8 cycles Drug: Standard chemotherapy As prescribed
2: Active Comparator	Drug: Standard chemotherapy As prescribed

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269113

Locations

Germany

STRALSUND, Germany, 18435

LEIPZIG, Germany, 04315

BORNA, Germany, 04552

CHEMNITZ, Germany, 09120

BERLIN, Germany, 12200

BERLIN, Germany, 13122

POTSDAM, Germany, 14467

Frankfurt an der Oder, Germany, 15236

NEUBRANDENBURG, Germany, 17036

ROSTOCK, Germany, 18055

GÜSTROW, Germany, 18273

HALLE, Germany, 06120

SCHWERIN, Germany, 19049

MARBURG, Germany, 35043

BONN, Germany, 53127

ZELLA-MEHLIS, Germany, 98544

RIESA, Germany, 01589

ERFURT, Germany, 99089

NORDHAUSEN, Germany, 99734

TRIER, Germany, 54290

JENA, Germany, 07740

MAGDEBURG, Germany, 39130

DÜLMEN, Germany, 48249

Leipzig, Germany, 04103

DRESDEN, Germany, 01307

MAGDEBURG, Germany, 39120

COTTBUS, Germany, 03042

JENA, Germany, 07743

BOCHUM, Germany, 44791

GREIFSWALD, Germany, 17487

HALLE, Germany, 06110

DRESDEN, Germany, 01067

ROSTOCK, Germany, 18057

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	M39023
Study First Received:	December 22, 2005
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00269113
Health Authority:	Germany: Paul-Ehrlich-Institut

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse

Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Mantle cell lymphoma
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009