A Phase 3 Open Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects With Previously Untreated Follicular Lymphoma (RELEVANCE)
Follicular Lymphoma
About this trial
This is an interventional treatment trial for Follicular Lymphoma focused on measuring follicular lymphoma, non-hodgkins follicular lymphoma, treatment for follicular lymphoma, rituximab treatment, rituximab and lenalidomide treatment
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed CD20+ follicular lymphoma grade 1, 2 or 3a
- Have no prior systemic treatment for lymphoma.
- Must be in need of treatment
- Bi-dimensionally measurable disease with at least one mass lesion > 2 cm that was not previously irradiated.
- Stage II, III or IV disease.
- Must be ≥ 18 years and sign an informed consent.
- Performance status ≤ 2 on the ECOG scale.
- Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow)
- Willing to follow pregnancy precautions
Exclusion Criteria:
- Clinical evidence of transformed lymphoma by investigator assessment or Grade 3b follicular lymphoma.
- Patients taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to < 10 mg/day prednisone (over these 4 weeks).
- Major surgery (excluding lymph node biopsy) within 28 days prior to signing informed consent.
- Known Seropositive for or active viral infection with hepatitis B virus (HBV), hepatitis C virus (HCV)or human immunodeficiency virus (HIV).
- Life expectancy < 6 months.
- Known sensitivity or allergy to murine products.
- Prior history of malignancies, other than follicular lymphoma, unless the patient has been free of the disease for ≥ 10 years.
- Prior use of lenalidomide.
- Neuropathy > Grade 1.
- Presence or history of CNS involvement by lymphoma.
- Patients who are at a high risk for a thromboembolic event and are not willing to take venous thromboembolic (VTE) prophylaxis.
- serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) > 3x upper limit of normal (ULN), except in patients with documented liver or pancreatic involvement by lymphoma
- total bilirubin > 2.0 mg/dl (34 µmol/L) except in cases of Gilberts Syndrome and documented liver involvement by lymphoma
- creatinine clearance of < 30 mL/min
- Pregnant or lactating females.
- Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study, or which confounds the ability to interpret data from the study.
Sites / Locations
- Concord Repatriation General Hospital
- Nepean Hospital
- Wollongong Hospital
- CHU Mont-Godinne
- Tom Baker Cancer Centre
- Cross Cancer Institute
- Fraser Valley Cancer Centre
- BCCA - Vancouver Cancer Centre
- Moncton Hospital
- Atlantic Health Sciences Corp - Saint John Regional Hospital
- Sunnybrook Health Sciences Centre
- UHN-Princess Margaret Hospital
- CHUM Hopital Notre-Dame
- McGill University Department of Oncology
- Hôpital de l'Enfant-Jesus, CHU de Quebec
- Saskatoon Cancer Centre
- CHU Claude Huriez
- Medizinische Klinik der Universität Tübingen
- Uniklinik Köln
- LMU Munchën - Klinikum Grosshadern
- Sant'Andrea Hospital
- Policlinico Sant'Orsola-Malpighi
- Instituto Português Oncologia
- Hospital Virgen del Rocio
- Hospital Universitario Mutua de Terrassa
- Hospital Universitario de Canarias
- Hospital Son Llatzer
- Hospital Clínico de Barcelona
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitario Vall d´Hebron
- Institut Català d'Oncologia de Girona (ICO Girona)
- Hospital Ramon y Cajal
- Hospital Costa del Sol
- Hospital Universitario Salamanca
- Hospital Clínico Universitario de Valencia
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Lenalidomide + Rituximab
Control
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 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.
• ONE of the following: Rituximab - CHOP, Rituximab - CVP, Rituximab - Bendamustine. 7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.