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

Sponsor

Jurgen Barth (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00877214

Collaborator

Sponsor GmbH (Other)

1,272

Enrollment

Location

Arms

252

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

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

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 Design

Study Type:

Interventional

Actual Enrollment :

1272 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Actual Study Start Date :

Apr 1, 2009

Anticipated Primary Completion Date :

Apr 1, 2030

Anticipated Study Completion Date :

Apr 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

Progression free survival [5 years and ongoing]
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 [5 years and ongoing]
Time from randomization until treatment failure due to progression or not achieving any remission; time from achievin CR or PR until progression or relapse

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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 .