Phase 3
N=358
Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)
Lymphoma, Non-Hodgkin
Bottom Line
View on ClinicalTrials.gov: NCT01938001 ↗Enrolled (actual)
358
Serious AEs
19.7%
Results posted
Aug 2019
Primary outcome: Primary: Kaplan Meier Estimate of Progression Free Survival Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC) — 39.4; 14.1 months — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rituximab (Drug); Lenalidomide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Celgene
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan Meier Estimate of Progression Free Survival Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC) |
39.4; 14.1 | < 0.0001 sig |
| SECONDARY Durable Complete Response Rate (DCCR) as Assessed by the IRC According to the 2007 IWGRC |
25.3; 11.1 | 0.0006 sig |
| SECONDARY Kaplan-Meier Estimate of Overall Survival (OS) |
NA; NA | — |
| SECONDARY Percentage of Participants With an Objective Response as Assessed by the IRC According to the 2007 IWGRC |
77.5; 53.3 | < 0.0001 sig |
| SECONDARY Percentage of Participants With a Best Response of Complete Response as Assessed by the IRC According to the 2007 IWGRC |
33.7; 18.3 | = 0.0010 sig |
| SECONDARY Kaplan-Meier Estimate of Duration of Objective Response as Assessed by the IRC According to the 2007 IWGRC |
36.6; 21.7 | 0.0015 sig |
| SECONDARY Kaplan-Meier Estimate of Duration of Complete Response (DOCR) as Assessed by the IRC According to the 2007 IWGRC |
NA; NA | 0.2993 |
| SECONDARY Kaplan Meier Estimate of Event Free Survival as Assessed by the IRC According to the 2007 IWGRC |
27.6; 13.9 | < 0.0001 sig |
| SECONDARY Kaplan Meier Estimate of Time to Next Anti-Lymphoma Treatment (TTNLT) |
73.1; 31.8 | <0.0001 sig |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
174; 173; 159; 118; 134; 105 | — |
Summary
This double-blind randomized, parallel group study will evaluate the efficacy and safety of lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination with rituximab. Anticipated time on study treatment is 1 year.
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years at the time of signing the informed consent document.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
- Histologically confirmed marginal zone lymphoma or follicular lymphoma (grade 1, 2 or 3a; CD20+ by flow cytometry or histochemistry).
- Previously treated with at least one prior systemic chemotherapy, immunotherapy or chemoimmunotherapy and have received at least 2 previous doses of rituximab.
- Documented relapsed, refractory or progressive disease after treatment with systemic therapy and must not be rituximab-refractory.
- Investigator considers rituximab monotherapy appropriate.
- Bi-dimensionally measurable disease on cross sectional imaging by X-ray computed tomography (CT) or magnetic resonance imaging (MRI).
- Need of treatment for relapsed, progressed or refractory disease as assessed by the investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Adequate bone marrow function.
- Willingness to follow study visit schedule, pregnancy precautions and other protocol requirements.
Exclusion Criteria
- Histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or Grade 3b follicular lymphoma.
- Subjects taking corticosteroids during the last week prior to study treatment, unless administered at a dose equivalent to Grade 1.
- 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.
- Uncontrolled intercurrent illness.
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document.
- Pregnant or lactating females.
- 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.
Data sourced from ClinicalTrials.gov (NCT01938001). 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.