Lymphoma, Follicular
Conditions
Brief summary
This 2 stage study will compare the pharmacokinetics and safety profile of subcutaneous and intravenous rituximab in participants with follicular lymphoma. In the first stage, participants who have achieved at least a partial response after induction treatment with intravenous rituximab will be randomized to one of 3 treatment cohorts, to receive rituximab 375 milligram per square meter (mg/m\^2) intravenously, 375 mg/m\^2 subcutaneously or 625 mg/m\^2 subcutaneously, and pharmacokinetics evaluated on an ongoing basis. Upon selection of the subcutaneous dose (800 mg/m\^2) which results in rituximab trough plasma concentration (C trough) values comparable to those achieved with the intravenous formulation, participants in the second stage of the study will be randomized to receive either the subcutaneous or intravenous formulation to demonstrate comparability of the C trough levels with both routes of administration. Maintenance therapy will continue every 2 or 3 months with the subcutaneous formulation.
Interventions
DRUGRituximab
Rituximab subcutaneous injection at 1400 mg dose level, administered every 2 or 3 months.
Sponsors
Hoffmann-La Roche
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* CD20-positive follicular non-Hodgkin's lymphoma (NHL) * Documented partial or complete response a the end of induction treatment with rituximab * Must have completed induction treatment, and received at least 1 dose of intravenous rituximab maintenance treatment * Eastern Cooperative Oncology Group (ECOG) performance status of less than and equal to (\<=) 2 * Life expectancy of greater than and equal to (\>=) 6 months
Exclusion criteria
* Histological evidence of transformation of NHL, or types of NHL other than follicular lymphoma * Presence or history of central nervous system disease * History of malignancy other than follicular NHL * Recent major surgery (within 4 weeks prior to screening), excluding lymph node biopsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimum Observed Plasma Trough Concentration (C trough) | Up to 29 months |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the Curve From Time Zero to end of Dosing Interval (AUCtau) | Up to 29 months |
| Maximum Observed Plasma Concentration (Cmax) | Up to 29 months |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Up to 29 months |
| Plasma Decay Half-Life (t1/2) | Up to 29 months |
| Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) | Up to 29 months |
Countries
Argentina, Australia, Brazil, Canada, Czechia, Denmark, Ecuador, Finland, France, Israel, Italy, Mexico, Norway, Peru, Poland, Russia, Slovakia, South Korea, Spain, Sweden, Switzerland, United Kingdom
Outcome results
None listed