The purpose of this study is to find out if lenalidomide when given along with rituximab can help to control the disease and also increase the length of your response (complete or partial response) compared to the standard of care rituximab chemotherapy treatment.
Follicular Lymphoma (FL) is a cancer of a B lymphocyte, a type of white blood cell. FL is typically a slowly progressing but incurable disease. Follicular lymphoma cells produce a specific defect in the patient's immune system impairing their ability to control their cancer. Lenalidomide has been shown to reverse the specific immune defect caused by FL in the patient. By including lenalidomide, the RELEVANCE study aims to eliminate the cancer while restoring the patient's immune competence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,030
• Rituximab, 375 mg/m2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
• Lenalidomide dose 20-mg on days 2-22 every 28 days x 6 cycles, if CR then 10-mg on days 2-22 every 28 days for 12 cycles. PR after 6 cycles, continue 20 mg for 3\~6 cycles and then 10 mg on days 2-22 every 28-day cycles for upto 18 cycles
six cycles of R-CHOP in 21 day cycles followed by two 21 day cycles of 375 mg/m2 rituximab; and 7 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles
eight cycles of R-CVP in 21 day cycles; and 7 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles,
six cycles of R-B in 28 day cycles and 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Nepean Hospital
Penrith, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
CHU Mont-Godinne
Yvoir, Belgium
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
COMPLETE RESPONSE RATE
Complete response (CR/CRu) rate at 120 weeks Response evaluation was as defined by International Working Group (IWG) Response Criteria (Cheson 1999). Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms if present before therapy.
Time frame: Timeframe: CR/CRu rate at 120 weeks
Progression Free Survival (PFS)
PFS is defined as the time from the start of study drug therapy to the 1st observation of disease progression or death due to any cause.
Time frame: up to 13 years
Number of participants with adverse events
Time frame: up to13 years
Time to Treatment Failure (TTF)
Time frame: up to13 years
Event Free Survival (EFS)
Time frame: up to13 years
Time to Next Anti-Lymphoma Treatment (TTNLT),
Time frame: up to13 years
Time to Next Chemotherapy Treatment (TTNCT)
Time frame: up to13 years
Overall Survival (OS)
Time frame: up to13 years
Overall response rate at 120 weeks by International Working Group (IWG) 1999 criteria
Time frame: up to13 years
Health related quality of life as measured by the EORTC QLQ-C30
Time frame: up to13 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Edmonton, Alberta, Canada
Fraser Valley Cancer Centre
Surrey, British Columbia, Canada
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Moncton Hospital
Moncton, New Brunswick, Canada
Atlantic Health Sciences Corp - Saint John Regional Hospital
Halifax, Nova Scotia, Canada
...and 25 more locations