Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Active	18 to 80	Other	NHL 7-2008 NCT00877214

Trial Description

Summary

The purpose of this study is to determine if an extended maintenance therapy with Rituximab in follicular and a maintenance therapy in other indolent and mantle cell lymphomas has advantages compared to a shorter or no maintenance therapy.

Further Study Information

Results from several randomised studies show a clinical benefit of a maintenance therapy with rituximab in follicular lymphomas. The advantage of a maintenance therapy in other indolent and mantle cell lymphomas is - due to the lower incidence of these diseases- not well investigated.

This study tries to determine the significance of an extended maintenance therapy with rituximab in follicular lymphomas and the significance of a maintenance therapy other indolent and mantle cell lymphomas compared to observation.

Eligibility Criteria

Inclusion Criteria:

• Patients with histological verified CD20-positive B-Cell-Lymphoma of the following entities:

• Follicular Lymphoma Grade 1 and 2

• Lymphoplasmocytic lymphoma / Immunocytoma (Morbus Waldenström) and small cell lymphocytic lymphoma (CLL without leukemic hemogram)

• Marginal zone lymphoma, nodal and extra nodal

• Mantle cell lymphoma

• No prior therapy with cytotoxics, interferon or monoclonal antibodies

• Need for therapy, except mantle cell lymphomas

• Stadium III or IV or Stadium with II bulky disease (> 7 cm diameter, or 3 lesions > 5 cm)

• General condition WHO 0-2

• Age min. 18 years, max. 80 years

• Negative pregnancy test, contraceptives mandatory for women of child-bearing age

• Actual histology, not older than 6 months required

• Written informed consent

Exclusion Criteria:

• Patients not meeting the inclusion criteria above

• Possibility of a primary radiation therapy with curative intention

• Pretreatment, except a single, localized radiation therapy (radiation field not larger than 2 adjacent lymph node regions)

• Co-morbidities, excluding a therapy according to the protocol:

• severe, medicinal not adjustable hypertension

• severe limited capacity of the heart (NYHA III or IV), the lung (WHO-Grade III or IV), the liver and kidneys (creatinin > 2 mg/dl, GOT and GPT or bilirubin 3 x ULN), except if caused by lymphoma

• severe, medicinal not adjustable diabetes mellitus

• active autoimmune disease

• active infection, requiring antibiotic therapy

• Patients with proven HIV-infection

• Active replicating hepatitis-Infection

• Severe psychiatric diseases

• Lacking or anticipated non-compliance

• Known hypersensitivity against the active components or additives or mouse- proteins

• Pregnant or nursing women

• Patients with a secondary malignancy or malignant disease in his history if, curative surgery can not be doubtless assured .

Trial Contact Information

Trial Lead Organizations/Sponsors

Universitaetsklinikum Giessen und Marburg GmbH - Giessen

Mathias Rummel, Dr

Principal Investigator

Mathias Rummel, Dr		Ph: +496419942 Ext.650
		Email: mathias.rummel@innere.med.uni-giessen.de

Jürgen Barth		Ph: +496419942 Ext.603
		Email: juergen.barth@innere.med.uni-giessen.de

Germany
	Giessen
	Universitaetsklinikum Giessen und Marburg GmbH - Giessen
		Mathias Rummel, Dr.	Ph: +496419942 Ext.650
			Email: mathias.rummel@innere.med.uni-giessen.de
		Jürgen Barth	Ph: +496419942 Ext.603
			Email: juergen.barth@innere.med.uni-giessen.de
		Mathias Rummel, Dr	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00877214
Information obtained from ClinicalTrials.gov on April 06, 2009