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

Primary Purpose

Follicular Lymphomas, Immunocytomas, Marginal Zone Lymphomas

Status
Active
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Rituximab
Rituximab / observation
Sponsored by
Jurgen Barth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Follicular Lymphomas focused on measuring Bendamustine, Rituximab, Significance of maintenance therapy, Efficacy and safety

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

  • StiL Head Office; Justus-Liebig-University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rituximab

Standard

Arm 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

Rituximab / Observation

Outcomes

Primary Outcome Measures

Progression free survival
Time from randomization until progress or death of any course

Secondary Outcome Measures

Remission rate and duration; event free-, progression free-, disease free- and over all survival
Time from randomization until treatment failure due to progression or not achieving any remission; time from achievin CR or PR until progression or relapse

Full Information

First Posted
April 6, 2009
Last Updated
May 17, 2022
Sponsor
Jurgen Barth
Collaborators
Sponsor GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00877214
Brief Title
Significance of Duration of Maintenance Therapy With Rituximab in Non-Hodgkin Lymphomas
Acronym
MAINTAIN
Official Title
Prospective Randomized Multicenter Study in First-line Treatment of Advanced progredIeNT Follicular And Other IndoleNt and Mantle Cell Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2009 (Actual)
Primary Completion Date
April 2030 (Anticipated)
Study Completion Date
April 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jurgen Barth
Collaborators
Sponsor GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphomas, Immunocytomas, Marginal Zone Lymphomas, Mantle-Cell Lymphomas, Lymphocytic Lymphoma, Non-Hodgkin's Lymphoma
Keywords
Bendamustine, Rituximab, Significance of maintenance therapy, Efficacy and safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituximab
Arm Type
Experimental
Arm 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
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Rituximab / Observation
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Mabthera(R), Rituxan(R)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Rituximab / observation
Other Intervention Name(s)
Mabthera(R), Rituxan(R)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Progression free survival
Description
Time from randomization until progress or death of any course
Time Frame
5 years and ongoing
Secondary Outcome Measure Information:
Title
Remission rate and duration; event free-, progression free-, disease free- and over all survival
Description
Time from randomization until treatment failure due to progression or not achieving any remission; time from achievin CR or PR until progression or relapse
Time Frame
5 years and ongoing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathias Rummel, Dr
Organizational Affiliation
University of Giessen
Official's Role
Principal Investigator
Facility Information:
Facility Name
StiL Head Office; Justus-Liebig-University
City
Giessen
ZIP/Postal Code
35392
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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

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