Phase 3
Completed N=1,030
Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma
Source: ClinicalTrials.gov NCT01476787 ↗Enrolled (actual)
1,030
Serious AEs
32.6%
Results posted
May 2025
Primary outcomePrimary: Complete Response Rate (CR/CRu) at 120 Weeks by Independent Central Review — 48.1; 53.0 Percent of participants — p=0.128
◆ Published Evidence
Highly cited
364citations · ~46 / year
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
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.
Linked Publications (4)
-
Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.
-
Combined lenalidomide, low-dose dexamethasone, and rituximab achieves durable responses in rituximab-resistant indolent and mantle cell lymphomas.
-
Follicular lymphoma comprises germinal center-like and memory-like molecular subtypes with prognostic significance.
-
Lenalidomide plus rituximab for previously untreated advanced follicular lymphoma: the 10-year RELEVANCE trial analysis.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.