Phase 3
N=124
A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular Lymphoma
Lymphoma, Follicular
Bottom Line
View on ClinicalTrials.gov: NCT02569996 ↗Enrolled (actual)
124
Serious AEs
11.3%
Results posted
Dec 2015
Primary outcome: Primary: Event-free Survival — 53.944 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rituximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event-free Survival |
53.944 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
14; 32 | — |
| SECONDARY Overall Survival (OS) |
72.959 | — |
| SECONDARY Time to Progression (TTP) |
56.024 | — |
| SECONDARY Time to Next Anti-lymphoma Treatment (TTNLT) |
59.236 | — |
| SECONDARY Duration of Response (DR) |
63.159 | — |
| SECONDARY Disease-free Survival (DFS) |
66.737 | — |
Summary
This study will evaluate the efficacy, safety, and tolerability of long-term maintenance therapy with rituximab in participants with advanced follicular lymphoma who have had a positive response to first-line treatment with a rituximab-containing regimen. The anticipated time on study treatment is 2 years, and the target sample size is 124 individuals.
Eligibility Criteria
Inclusion Criteria
- Adult participants greater than (>) 18 years of age
- Histologically confirmed follicular lymphoma Grade 1, 2, or 3a with lymph node biopsy within 4 months of induction treatment
- No previous anti-lymphoma treatment before induction chemotherapy (first-line-treated participants only are eligible)
- Verified complete or partial remission after first-line induction therapy including rituximab
Exclusion Criteria
- Grade 3b follicular lymphoma
- Transformation to high-grade lymphoma (except to Grade 3a) of previously existing follicular lymphoma
- Presence of central nervous system lymphoma
- Acquired immunodeficiency syndrome-related lymphoma
- Other primary malignancy (other than squamous cell cancer of the skin or in situ cancer of the cervix) for which the participant has not been disease-free for greater than or equal to (>=) 5 years
Data sourced from ClinicalTrials.gov (NCT02569996). 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.