Significance of Duration of Maintenance Therapy With Rituximab in Non-Hodgkin Lymphomas

• Status: Active, not recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jurgen Barth
• Collaborator: Sponsor GmbH
• Treatments: Bendamustine Hydrochloride; Rituximab

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 .