Phase 3
N=1,030
Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma
Follicular Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01476787 ↗Enrolled (actual)
1,030
Serious AEs
32.6%
Results posted
May 2025
Primary outcome: Primary: Complete Response Rate (CR/CRu) at 120 Weeks by Independent Central Review — 48.1; 53.0 Percent of participants — p=0.128
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rituximab (Drug); Lenalidomide (Drug); Rituximab-CHOP (Drug); Rituximab-CVP (Drug); Rituximab-Bendamustine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celgene
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response Rate (CR/CRu) at 120 Weeks by Independent Central Review |
48.1; 53.0 | 0.128 |
| PRIMARY Progression-free Survival (PFS) |
120.2; 123.8 | 0.406 |
| SECONDARY Complete Response Rate (CR) at 120 Weeks Per Independent Central Review |
27.7; 32.7 | — |
| SECONDARY Event-free Survival (EFS) |
130.6; 132.3 | — |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
| SECONDARY Time to Next Anti-Lymphoma Treatment (TTNLT) |
NA; NA | — |
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 compared to the available standard combination chemotherapy treatment for Follicular Lymphoma.
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
Data sourced from ClinicalTrials.gov (NCT01476787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.