NCT01476787CompletedPhase 3
Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma
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
Source: ClinicalTrials.gov · Last updated 14 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1030 (actual)
- First submitted
- 18 Nov 2011
- Start date
- 29 Dec 2011
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- Celgene
- Diseases
- Follicular lymphoma
- NCT number
- NCT01476787
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 1030
- From 29 Dec 2011 to the primary completion date, 30 Apr 2024
- 36 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery (excluding lymph node biopsy) within 28 days prior to signing informed consent.
Other illness
- 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
Lab values
- 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
Other
- Clinical evidence of transformed lymphoma or Grade 3b follicular lymphoma.
- At high risk for a venous thromboembolic event (VTE) and not willing to take VTE prophylaxis
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 40722 Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| Local Institution - 40922 Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Local Institution - 40422 Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Local Institution - 40122 Coordinator of this site? Confirm its status | Isehara City, Kanagawa | Japan | Unknown status |
| Local Institution - 40322 Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Local Institution - 40222 Coordinator of this site? Confirm its status | Koto-ku | Japan | Unknown status |
| Local Institution - 40622 Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Local Institution - 41122 Coordinator of this site? Confirm its status | Minato-ku | Japan | Unknown status |
| Local Institution - 41022 Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Local Institution - 40522 Coordinator of this site? Confirm its status | Shizuoka | Japan | Unknown status |
| Local Institution - 50503 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Local Institution - 50403 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Local Institution - 54103 Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| Local Institution - 54403 Coordinator of this site? Confirm its status | Cherry Hill | United States | Unknown status |
| Local Institution - 50803 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Local Institution - 51603 Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| Local Institution - 51203 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Local Institution - 52503 Coordinator of this site? Confirm its status | Englewood | United States | Unknown status |
| Local Institution - 51803 Coordinator of this site? Confirm its status | Fullerton | United States | Unknown status |
| Local Institution - 53703 Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| Local Institution - 51103 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Local Institution - 52203 Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Local Institution - 52003 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Local Institution - 54003 Coordinator of this site? Confirm its status | Lubbock | United States | Unknown status |
| Local Institution - 50903 Coordinator of this site? Confirm its status | Morristown | United States | Unknown status |
| Local Institution - 51303 Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Local Institution - 50203 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Local Institution - 52403 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Local Institution - 51703 Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Local Institution - 53303 Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Local Institution - 52703 Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Local Institution - 53003 Coordinator of this site? Confirm its status | Southfield | United States | Unknown status |
| Local Institution - 54303 Coordinator of this site? Confirm its status | Sparta | United States | Unknown status |
| Local Institution - 51003 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Local Institution - 53803 Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Local Institution - 53603 Coordinator of this site? Confirm its status | Westminster | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.