A Phase 3 interventional study of rituximab in Lymphoma, sponsored by Swiss Group for Clinical Cancer Research. Completed at 26 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-15.
Sponsored by Swiss Group for Clinical Cancer Research · Phase 3, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study.
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.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 270 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Swiss Group for Clinical Cancer Research is the lead sponsor of 107 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed follicular lymphoma
Previously untreated disease OR meets 1 of the following criteria for response to prior treatment:
Stable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
More than 4 weeks since prior regular administration of corticosteroids
Radiotherapy
Prior radiolabeled anti-CD20 therapy (administered alone or in combination with cytostatic drugs) allowed provided patient has achieved partial or complete response after the therapy
Surgery
Other
Rituximab 375 mg/m2 every 2 months x4
Biological: rituximab
Rituximab 375 mg/m2 every 2 months for 5 years or until PD, relapse or unacceptable toxicity
Biological: rituximab
comparing two maintenance schedules of Rituximab
Also known as: MABTHERA
Event-free survival
Time frame: at 10 years
Progression-free survival
Time frame: at 10 years
Overall survival
Time frame: at 10 years
Adverse reactions during and after maintenance treatment
Time frame: 10 years
Plan to share: No
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Swiss Group for Clinical Cancer Research