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

Jurgen Barth

Status and phase: Active, not recruiting; Phase 3

Conditions: Lymphocytic Lymphoma; Non-Hodgkin's Lymphoma; Immunocytomas; Follicular Lymphomas; Mantle-Cell Lymphomas; Marginal Zone Lymphomas

Treatments: Drug: Rituximab / observation; Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00877214

NHL 7-2008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,272 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,272 participants in 2 patient groups

Rituximab

Experimental group

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

Treatment:

Drug: Rituximab

Standard

Active Comparator group

Description:

Rituximab / Observation

Treatment:

Drug: Rituximab / observation