Status:
ACTIVE_NOT_RECRUITING
Significance of Duration of Maintenance Therapy With Rituximab in Non-Hodgkin Lymphomas
Lead Sponsor:
Jurgen Barth
Collaborating Sponsors:
Sponsor GmbH
Conditions:
Follicular Lymphomas
Immunocytomas
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
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 cel...
Eligibility Criteria
Inclusion
- 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
- 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 .
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
1272 Patients enrolled
Trial Details
Trial ID
NCT00877214
Start Date
April 1 2009
End Date
December 1 2024
Last Update
August 22 2024
Active Locations (1)
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1
StiL Head Office; Justus-Liebig-University
Giessen, Germany, 35392