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

Brief Title

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

Official Title

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

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 to a shorter or no maintenance therapy.

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 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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Progression free survival

Secondary Outcome

 Remission rate and duration; event free-, progression free-, disease free- and over all survival

Condition

Follicular Lymphomas

Intervention

Rituximab

Study Arms / Comparison Groups

 Rituximab

Description:  Follicular Lymphomas: Rituximab 375 mg/m² for additional 2 years after 2 years of standard maintainance All other lymphomas: Rituximab 375 mg/m² for 2 years as maintainance. From 2014 only Morbus Waldenstroem: Rituximab 1.400 mg absolute s. c. injection

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

April 1, 2009

Completion Date

April 2030

Primary Completion Date

April 2030

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 .

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Mathias Rummel, Dr, ,

Location Countries

Germany

Location Countries

Germany

Administrative Informations

NCT ID

NCT00877214

Organization ID

NHL 7-2008

Responsible Party

Sponsor-Investigator

Study Sponsor

Jurgen Barth

Collaborators

 Sponsor GmbH

Study Sponsor

Mathias Rummel, Dr, Principal Investigator, University of Giessen

Verification Date

May 2022