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

This study is currently recruiting participants.
Verified February 2013 by University of Giessen
Sponsor:
Collaborator:
Sponsor GmbH
Information provided by (Responsible Party):
Jurgen Barth, University of Giessen
ClinicalTrials.gov Identifier:
NCT00877214
First received: April 6, 2009
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Follicular Lymphomas
Immunocytomas
Marginal Zone Lymphomas
Mantle-Cell Lymphomas
Non-Hodgkin's Lymphoma
Drug: Rituximab
Drug: Rituximab / observation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Multicenter Study in First-line Treatment of Advanced progredIeNT Follicular And Other IndoleNt and Mantle Cell Lymphomas

Resource links provided by NLM:


Further study details as provided by University of Giessen:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 5 years and ongoing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Remission rate and duration; event free-, progression free-, disease free- and over all survival [ Time Frame: 5 years and ongoing ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1134
Study Start Date: April 2009
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab Drug: Rituximab
Follicular Lymphomas: induction therapy with bendamustine + rituximab. If CR or PR: Maintenance therapy with rituximab every 2 months for 4 years Immunocytomas, marginal zone and mantle cell lymphomas: induction therapy with bendamustine + rituximab If CR or PR: Maintenance therapy with rituximab every 2 months for 2 years
Other Names:
  • Mabthera(R)
  • Rituxan(R)
Active Comparator: Standard
Rituximab / Observation
Drug: Rituximab / observation
Follicular Lymphomas:induction therapy with bendamustine + rituximab If CR or PR: Maintenance therapy with rituximab every 2 months for 2 years (standard) Immunocytomas, marginal zone and mantle cell lymphomas: induction therapy with bendamustine + rituximab If CR or PR: observation (standard)
Other Names:
  • Mabthera(R)
  • Rituxan(R)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 .
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877214

Contacts
Contact: Mathias Rummel, Dr +4964198542 ext 650 mathias.rummel@innere.med.uni-giessen.de
Contact: Jürgen Barth +4964198542 ext 603 juergen.barth@innere.med.uni-giessen.de

Locations
Germany
StiL Head Office; Justus-Liebig-University Recruiting
Giessen, Germany, 35392
Contact: Mathias Rummel, Dr.    +4964198542 ext 650    mathias.rummel@innere.med.uni-giessen.de   
Contact: Jürgen Barth    +4964198542 ext 603    juergen.barth@innere.med.uni-giessen.de   
Principal Investigator: Mathias Rummel, Dr         
Sponsors and Collaborators
Jurgen Barth
Sponsor GmbH
Investigators
Principal Investigator: Mathias Rummel, Dr University of Giessen
  More Information

Additional Information:
No publications provided

Responsible Party: Jurgen Barth, Professor Mathias Rummel, University of Giessen
ClinicalTrials.gov Identifier: NCT00877214     History of Changes
Other Study ID Numbers: NHL 7-2008
Study First Received: April 6, 2009
Last Updated: February 11, 2013
Health Authority: Germany: Paul-Ehrlich-Institut
Germany: Ethics Commission

Keywords provided by University of Giessen:
Bendamustine
Rituximab
Significance of maintenance therapy
Efficacy and safety

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Bendamustine
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 16, 2014