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
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.
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.