Clinical trial
A Phase 3 Open-Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Chemotherapy in Subjects With Previously Untreated Follicular Lymphoma
Name
RV-FOL-GELARC-0683C
Description
The purpose of this study is to evaluate the effect of the combined treatment of lenalidomide and rituximab in controlling the Follicular Lymphoma disease and also increase the length of response compared to the available standard combination chemotherapy treatment for Follicular Lymphoma.
Trial arms
Trial start
2011-12-29
Estimated PCD
2024-04-30
Trial end
2024-04-30
Status
Active (not recruiting)
Phase
Early phase I
Treatment
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.
Arms:
Lenalidomide + Rituximab
Lenalidomide
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
Arms:
Lenalidomide + Rituximab
Other names:
Revlimid
Rituximab-CHOP
7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
Arms:
Control
Rituximab-CVP
7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
Arms:
Control
Rituximab-Bendamustine
7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
Arms:
Control
Size
255
Primary endpoint
Complete Response Rate (CR/CRu) at 120 weeks
Up to approximately 2.5 years
Progression free survival (PFS)Follicular lymphoma
Up to 12 years
Eligibility criteria
Inclusion Criteria:
* Histologically confirmed follicular lymphoma grade 1, 2 or 3a, Stage II-IV
* Have no prior systemic treatment for lymphoma
* Symptomatic follicular lymphoma requiring treatment.
* Age ≥18 years
* Eastern Cooperative oncology group performance status 0-2
* Willing to follow pregnancy precautions
Exclusion Criteria:
* Clinical evidence of transformed lymphoma or Grade 3b follicular lymphoma.
* 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), human immunodeficiency virus (HIV)
* Known sensitivity or allergy to murine products.
* Presence or history of central nervous system involvement by lymphoma
* At high risk for a venous thromboembolic event (VTE) and not willing to take VTE prophylaxis
* Any of the following laboratory abnormalities:
* serum aspartate transaminase or alanine transaminase \> 3x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma
* total bilirubin \> 2.0 mg/dl (34 µmol/L) except in cases of Gilberts Syndrome and documented liver or pancreatic involvement by lymphoma
* creatinine clearance of \< 30 mL/min
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 255, 'type': 'ACTUAL'}}
Updated at
2024-04-12
1 organization
5 products
1 indication
Organization
CelgeneProduct
RituximabIndication
Follicular LymphomaProduct
LenalidomideProduct
Rituximab-CHOPProduct
Rituximab-CVPProduct
Rituximab-Bendamustine