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Prospective Randomized Multicenter Study in First-line Treatment of Advanced progredIeNT Follicular And Other IndoleNt and Mantle Cell Lymphomas

Phase 2/Phase 3
18 Years
80 Years
Open (Enrolling)
Follicular Lymphomas, Immunocytomas, Marginal Zone Lymphomas, Mantle-Cell Lymphomas, Non-Hodgkin's Lymphoma

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Trial Information

Prospective Randomized Multicenter Study in First-line Treatment of Advanced progredIeNT Follicular And Other IndoleNt and Mantle Cell Lymphomas

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.

Inclusion Criteria:

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

- 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

- 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 .

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

5 years and ongoing

Safety Issue:


Principal Investigator

Mathias Rummel, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Giessen


Germany: Paul-Ehrlich-Institut

Study ID:

NHL 7-2008



Start Date:

April 2009

Completion Date:

April 2020

Related Keywords:

  • Follicular Lymphomas
  • Immunocytomas
  • Marginal Zone Lymphomas
  • Mantle-Cell Lymphomas
  • Non-Hodgkin's Lymphoma
  • Bendamustine
  • Rituximab
  • Significance of maintenance therapy
  • Efficacy and safety
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Mantle-Cell