Clinical trial NCT02569996: A Study of Long-Term Rituximab (MabThera) Maintenance Therapy in Participants With Advanced Follicular Lymphoma
Official title: A Multicenter, Phase III, Open-label Study Evaluating the Benefit of a Long-term Effect of MabThera (Rituximab) Maintenance Therapy in Patients With Advanced Follicular Lymphoma After Induction of Response (CR[u] or PR) With MabThera (Rituximab) Containing First-line Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lymphoma, Follicular
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-10-07
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Event-free Survival
timeFrame: From randomization to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first, assessed up to 5 years
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 27 months
measure: Overall Survival (OS)
timeFrame: From randomization until death, assessed up to 5 years
measure: Time to Progression (TTP)
timeFrame: From baseline (Week 0) to disease progression, relapse, death from the follicular lymphoma or institution of a new regimen, whichever occurs first, assessed up to 5 years
measure: Time to Next Anti-lymphoma Treatment (TTNLT)
timeFrame: From baseline (Week 0) to institution of a new antilymphoma regimen, assessed up to 5 years
measure: Duration of Response (DR)
timeFrame: From first documented response to induction treatment to relapse or progression or death, assessed up to 5 years
measure: Disease-free Survival (DFS)
timeFrame: From first documented complete response to induction treatment to relapse or progression or death, whichever occurs first, assessed up to 5 years
Other outcomes:
Locations:
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Kaposvar
country: Hungary
city: Miskolc
country: Hungary
city: Nyíregyháza
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Szekszard
country: Hungary
city: Szolnok
country: Hungary
city: Szombathely
country: Hungary
city: Székesfehérvár
country: Hungary
city: Tatabánya
country: Hungary
city: Veszprem
country: Hungary
city: Zalaegerszeg
country: Hungary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: