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

Sponsor
Swiss Cancer Institute
Study ID
NCT00227695
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
    comparing two maintenance schedules of Rituximab

Study Details

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.

Key Dates

Start date
Jun 8, 2004
Status verified
May 2019
Primary completion
May 3, 2013
Completion
Dec 19, 2017

Study Design

Enrollment
270 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A: Rituximab every 2 months x4
    Rituximab 375 mg/m2 every 2 months x4
  • Active Comparator: Arm B: Rituximab (5 years)
    Rituximab 375 mg/m2 every 2 months for 5 years or until PD, relapse or unacceptable toxicity

Primary Outcome Measure

Event-free survival [ Time Frame: at 10 years ]

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