Status:
COMPLETED
Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma
Lead Sponsor:
Celgene
Collaborating Sponsors:
The Lymphoma Academic Research Organisation
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 comp...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 29 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
1030 Patients enrolled
Trial Details
Trial ID
NCT01476787
Start Date
December 29 2011
End Date
April 30 2024
Last Update
May 14 2025
Active Locations (36)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution - 54103
Chandler, Arizona, United States, 85224
2
Local Institution - 51803
Fullerton, California, United States, 92835
3
Local Institution - 52003
Los Angeles, California, United States, 90095
4
Local Institution - 51603
Colorado Springs, Colorado, United States, 80909