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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 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: April 30, 2014
Last verified: April 2014
  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 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: 1272
Study Start Date: April 2009
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 30, 2014
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 July 29, 2014