A Phase IIIb, randomized study comparing maintenance therapy with subcutaneous rituximab continued until progression and observation in patients with relapsed or refractory, indolent non-Hodgkin’s lymphoma who completed and responded to rituximab-based immunochemotherapy induction and initial 2-year rituximab maintenance therapy administered subcutaneously.

Phase 1

• Conditions: Patients with relapsed or refractory CD20+ follicular non-Hodgkin’s lymphoma (NHL) Grade 1, 2 or 3a, or other CD20+ indolent NHL (Waldenström’s macroglobulinemia or lymphoplasmacytic lymphoma, marginal zone lymphoma), according to the WHO classification system.; MedDRA version: 19.0Level: LLTClassification code 10067070Term: Follicular B-cell non-Hodgkin's lymphomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2010-023407-95-SK
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-25
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• Age = 18 years.
• Histologically confirmed, CD20+ follicular NHL Grade 1, 2 or 3a, or other CD20+ indolent NHL (Waldenström’s macroglobulinemia or lymphoplasmacytic lymphoma, marginal zone lymphoma) according to the WHO classification system.
• Patients must have received, and must have relapsed or been refractory to, one or more lines of adequate therapy prior to enrolment, including at least one line consisting of immunotherapy and/or chemotherapy and/or radiotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status = 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350

Exclusion Criteria

• Transformation to high-grade lymphoma.
• Patients with aggressive lymphoma (e.g. mantle cell lymphoma).
• Presence or history of central nervous system (CNS) lymphomatous disease (e.g., CNS lymphoma or lymphomatous meningitis).
• Other malignancy within 5 years prior to enrolment, with the following exceptions (as long as curatively treated): carcinoma in situ of the cervix, squamous cell carcinoma of the skin, or basal cell skin cancer. Cervical carcinoma stage 1B or less, breast cancer in situ, or localized prostate cancer stage T1c or less may be considered, provided that the patient was treated with curative intent and has been relapse- and metastasis-free for at least 2 years prior to enrolment.
• Inadequate hepatic or renal function prior to the first rituximab induction dose.
• Known human immunodeficiency virus (HIV) infection.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified