Rituximab in Treating Patients With Follicular Non-Hodgkin's Lymphoma

Phase 3

Completed

• Conditions: Lymphoma
• Interventions: Biological: rituximab

• Registration Number: NCT00227695
• Lead Sponsor: Swiss Group for Clinical Cancer Research

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving rituximab over a short period of time is more effective than giving it over a long period of time in treating follicular non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying rituximab to see how well it works when given over a short period of time compared to when given over a long period of time in treating patients with follicular non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES:

Primary

* Compare the efficacy of induction therapy with rituximab followed by short- vs long-term maintenance therapy with rituximab, in terms of event-free survival, in patients with follicular non-Hodgkin's lymphoma.

Secondary

* Compare the safety of these regimens in these patients.

* Compare the pharmaeconomical aspects of these regimens in these patients.

* Compare the evolution of immunologic competence in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study.

* Induction therapy: Patients receive rituximab IV weekly in weeks 1-4 and undergo restaging between weeks 11-13. Patients with stable disease or progressive disease are taken off study. Patients achieving partial or complete response are stratified according to prior treatment status (untreated\* vs treated with or without anti-CD20 therapy), presence of bulky disease\*\* at study entry (yes vs no), and participating center. Patients are then randomized to 1 of 2 maintenance treatment arms.

NOTE: \*Patients treated with radiotherapy only are considered as therapy-naïve.

NOTE: \*\*Defined as a mass or lymph node conglomerate ≥ 5 cm diameter.

* Maintenance therapy: Patients start maintenance therapy within 7 days of randomization.

* Arm I: Patients receive rituximab IV every 2 months for 4 treatments.

* Arm II: Patients receive rituximab IV every 2 months for up to 5 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months until disease progression or relapse and then annually for up to 10 years after randomization.

PROJECTED ACCRUAL: A total of 270 patients will be accrued for this study within 3 years.

Study Timeline

• Study Start: 2004-06-08
• Study First Submitted: 2005-09-26
• Study First Submitted QC: 2005-09-26
• Study First Posted: 2005-09-28
• Primary Completion: 2013-05-03
• Study Completion: 2017-12-19
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-13
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B: Rituximab (5 years)	rituximab	Rituximab 375 mg/m2 every 2 months for 5 years or until PD, relapse or unacceptable toxicity
Arm A: Rituximab every 2 months x4	rituximab	Rituximab 375 mg/m2 every 2 months x4

Primary Outcome Measures

Name	Time	Method
Event-free survival	at 10 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	at 10 years
Progression-free survival	at 10 years
Adverse reactions during and after maintenance treatment	10 years

Trial Locations

Locations (26)

Clinical Center - Institute of Hematology; 🇧🇷 Sao Paulo, Brazil

Istituto Europeo di Oncologia IEO; 🇮🇹 Milano, Italy

Panorama Medical Centre; 🇿🇦 Cape Town, South Africa

Sandton Oncology Centre; 🇿🇦 Johannesburg, South Africa

Universitaetsspital Basel; 🇨🇭 Basel, Switzerland

Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli; 🇨🇭 Bellinzona, Switzerland

Clinical Center Skopje; 🇲🇰 Skopje, North Macedonia

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland

Klinik Hirslanden; 🇨🇭 Zurich, Switzerland

Clinical Center of Serbia; 🇷🇸 Belgrade, Serbia

NOU - National Institute for Oncology; 🇸🇰 Bratislava, Slovakia

Kantonspital Aarau; 🇨🇭 Aarau, Switzerland

St. Claraspital AG; 🇨🇭 Basel, Switzerland

Kantonsspital Baden; 🇨🇭 Baden, Switzerland

Kantonsspital Bruderholz; 🇨🇭 Bruderholz, Switzerland

Kantonsspital Graubuenden; 🇨🇭 Chur, Switzerland

Hopital Cantonal Universitaire de Geneve; 🇨🇭 Geneva, Switzerland

Hôpital Pourtalès; 🇨🇭 Neuchâtel, Switzerland

City Hospital Triemli; 🇨🇭 Zurich, Switzerland

Breitenbach Praxis Dr. Haberthür; 🇨🇭 Breitenbach, Switzerland

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Inselspital Bern; 🇨🇭 Bern, Switzerland

SpitalSTS AG Simmental-Thun-Saanenland; 🇨🇭 Thun, Switzerland

Kantonsspital; 🇨🇭 Liestal, Switzerland

Istituto Oncologico della Svizzera Italiana; 🇨🇭 Lugano, Switzerland

UniversitaetsSpital Zuerich; 🇨🇭 Zurich, Switzerland