Phase 3
N=503
Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.
Lymphoma, Non-Hodgkin
Bottom Line
View on ClinicalTrials.gov: NCT01996865 ↗Enrolled (actual)
503
Serious AEs
32.8%
Results posted
Jul 2025
Primary outcome: Primary: Progression Free Survival (PFS) — 263.1; 229.1 Weeks — p=0.3296
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lenalidomide (Drug); Rituximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celgene
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
263.1; 229.1 | 0.3296 |
| SECONDARY Overall Survival (OS) |
NA; NA | 0.1222 |
| SECONDARY Improvement of Response (IOR) |
20; 11.4 | — |
| SECONDARY Overall Response Rate (ORR) |
85.2; 79.5 | — |
| SECONDARY Complete Response Rate (CRR) |
60.7; 58.3 | — |
| SECONDARY Duration of Response (DOR) |
268.3; 306.0 | — |
| SECONDARY Time to Next Anti-lymphoma Treatment |
NA; NA | — |
| SECONDARY Time to Histological Transformation |
NA; NA | — |
| SECONDARY Duration of Complete Response (DOCR) |
298.0; NA | — |
| SECONDARY Participants Experiencing Treatment Emergent Adverse Events (TEAEs) |
499; 133; 120; 172; 57; 22 | — |
| SECONDARY Participants Experiencing Adverse Events Related to Vital Signs |
34; 9; 6; 22; 4; 5 | — |
| SECONDARY Participants With Grade 3 or Grade 4 Hematology Parameters |
31; 7; 0; 101; 19; 6 | — |
| SECONDARY Participants With Grade 3 or Grade 4 Serum Chemistry Parameters |
30; 8; 4; 4; 0; 1 | — |
Summary
Follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) are distinct histologic types of B-cell NHL. Lenalidomide is an immunomodulatory agent with direct and immune-mediated mechanisms of action, as well as clinical activity in NHL. Recent studies in frontline and relapsed/refractory NHL show high activity for lenalidomide plus rituximab (R2), supporting further study of this combination.
Eligibility Criteria
Inclusion Criteria
-- Age ≥18 years
- Histologically confirmed Follicular Lymphoma (FL, Grade 1, 2, 3a, or 3b), Transformed FL, Marginal Zone Lymphoma, or Mantle Cell Lymphoma
- Must have documented relapsed, refractory or Progressive Disease after last treatment with systemic therapy
- Bi-dimensionally measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance status < 2
- Adequate bone marrow function
- Willingness to follow pregnancy precautions
Exclusion Criteria
- Histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or Grade 3b follicular lymphoma
- Any medical condition (other than the underlying lymphoma) that requires chronic steroid use
- Subjects taking corticosteroids during the last 1 week prior treatment, unless administered at a dose equivalent to < 20 mg/day of prednisone
- Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 4 weeks use of radioimmunotherapy within 3 months
- 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. Subjects who are at a risk for a thromboembolic event and are not willing to take prophylaxis for it
- Any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT01996865). 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.