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

Non-Hodgkin's Lymphoma Clinical Trial

— MAINTAIN  

Official title:

Prospective Randomized Multicenter Study in First-line Treatment of Advanced progredIeNT Follicular And Other IndoleNt and Mantle Cell Lymphomas

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00877214
• Other study ID #: NHL 7-2008
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 1, 2009
• Est. completion date: April 2030

Study information

• Verified date: November 2023
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1272
• Est. completion date: April 2030
• Est. primary completion date: April 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Follicular Lymphomas
• Immunocytomas
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphocytic Lymphoma
• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Mantle-Cell
• Lymphoma, Non-Hodgkin
• Mantle-Cell Lymphomas
• Marginal Zone Lymphomas
• Non-Hodgkin's Lymphoma

Intervention

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
• 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)

Locations

Country	Name	City	State
Germany	StiL Head Office; Justus-Liebig-University	Giessen

Sponsors (2)

Lead Sponsor	Collaborator
Jurgen Barth	Sponsor GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	Time from randomization until progress or death of any course	5 years and ongoing
Secondary	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	5 years and ongoing