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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00877214
Recruitment Status : Active, not recruiting
First Posted : April 7, 2009
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
Sponsor GmbH
Information provided by (Responsible Party):
Jurgen Barth, University of Giessen

Tracking Information
First Submitted Date  ICMJE April 6, 2009
First Posted Date  ICMJE April 7, 2009
Last Update Posted Date April 19, 2019
Actual Study Start Date  ICMJE April 1, 2009
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2009)
Progression free survival [ Time Frame: 5 years and ongoing ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2009)
Remission rate and duration; event free-, progression free-, disease free- and over all survival [ Time Frame: 5 years and ongoing ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Significance of Duration of Maintenance Therapy With Rituximab in Non-Hodgkin Lymphomas
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Follicular Lymphomas
  • Immunocytomas
  • Marginal Zone Lymphomas
  • Mantle-Cell Lymphomas
  • Lymphocytic Lymphoma
  • Non-Hodgkin's Lymphoma
Intervention  ICMJE
  • 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)
  • 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)
Study Arms  ICMJE
  • 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
    Intervention: Drug: Rituximab
  • Active Comparator: Standard
    Rituximab / Observation
    Intervention: Drug: Rituximab / observation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 30, 2014)
1272
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2009)
874
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 .
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00877214
Other Study ID Numbers  ICMJE NHL 7-2008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jurgen Barth, University of Giessen
Study Sponsor  ICMJE Jurgen Barth
Collaborators  ICMJE Sponsor GmbH
Investigators  ICMJE
Principal Investigator: Mathias Rummel, Dr University of Giessen
PRS Account University of Giessen
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP