Overview

This trial is active, not recruiting.

Condition non-hodgkin's lymphoma
Treatments mabthera subcutaneous, mabthera intravenous
Phase phase 3
Target CD20
Sponsor Hoffmann-La Roche
Start date February 2011
End date November 2017
Trial size 410 participants
Trial identifier NCT01200758, 2010-021377-36, BO22334

Summary

This two-stage, multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, efficacy and safety of MabThera (rituximab) subcutaneous versus MabThera (rituximab) intravenous in patients with previously untreated follicular non-Hodgkin's lymphoma. Patients will be randomized to receive 375 mg/m² MabThera as intravenous infusion or 1400 mg MabThera given subcutaneously. In addition, patients will receive standard chemotherapy. Patients who achieved a complete or partial response after 8 treatment cycles, will receive maintenance treatment for a further maximum number of 12 cycles. Maintenance treatment cycles will be repeated every 8 weeks. The anticipated time on study treatment is 96 weeks.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
mabthera intravenous
MabThera intravenous infusion 375 mg/m2 at cycle 1 on day 0, day 1 and day 2 and at cycles 2-8 on day 1. In addition, standard chemotherapy is given. Additional maintenance treatment for a maximum of 12 cycles.
(Experimental)
mabthera subcutaneous
At cycle 1 on day 0, day 1 or day 2, MabThera is given as intravenous infusion 375 mg/m2. MabThera subcutaneous 1400 mg at cycle 2 on day 0 and at cycles 3-8 on day 1. In addition, standard chemotherapy is given. Additional maintenance treatment for a maximum of 12 cycles.

Primary Outcomes

Measure
Stage I: To estimate the ratio of trough serum concentrations of MabThera after subcutaneous administration to that obtained after intravenous administration
time frame: Day 21
Stage II: To estimate the overall response rate in each treatment arm at the end of induction treatment
time frame: Week 24 (Cycle 8)

Secondary Outcomes

Measure
Stage I: To compare observed MabThera serum concentrations (MabThera intravenous vs. subcutaneous) during induction treatment given every 3 weeks
time frame: Week 24 (Cycle 8)
Stage I: To explore additional MabThera pharmacokinetics parameter during induction treatment including, but not limited to, predicted pharmacokinetics parameter for induction regimens given every 4 weeks
time frame: Week 24 (Cycle 8)
Stage I: To compare overall response rate of MabThera subcutaneous and MabThera intravenous given in combination with chemotherapy as induction treatment at the end/completion of induction treatment
time frame: Week 24 (Cycle 8)
To compare peripheral blood B-cell depletion and repletion after MabThera subcutaneous and MabThera intravenous treatment
time frame: 96 weeks
To compare complete response rates of MabThera subcutaneous and MabThera intravenous given in combination with chemotherapy at the end/completion of the induction treatment
time frame: Week 24 (cycle 8)
To compare overall response rate and complete response rate of MabThera subcutaneous and MabThera intravenous at the end/completion of maintenance treatment
time frame: 96 weeks
To compare progression-free survival, event-free survival, overall survival of MabThera subcutaneous and MabThera intravenous when given in combination with chemotherapy during induction treatment followed by maintenance treatment as monotherapy
time frame: 96 weeks
To compare the safety profiles of MabThera subcutaneous and MabThera intravenous
time frame: 96 weeks
To compare the immunogenicity of MabThera subcutaneous and MabThera intravenous
time frame: 96 weeks
To compare observed MabThera serum Ctrough levels during induction treatment
time frame: Week 24 (Cycle 8)
To compare observed MabThera serum Ctrough levels during maintenance treatment
time frame: 96 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/=18 years of age - CD20-positive, follicular Non-Hodgkin's lymphoma grade 1, 2, 3a. A tumor biopsy must have been performed within 6 months before study entry with material available for central review. - No prior treatment - ECOG performance status 0-2 Exclusion Criteria: - Grade 3b follicular lymphoma - Transformation to high-grade lymphoma secondary to follicular lymphoma - Types of Non-Hodgkin's lymphoma other than follicular lymphoma - Presence or history of CNS disease - Corticoid therapy during the last 4 weeks, except prednisone treatment <20 mg per day

Additional Information

Official title A Two-stage Phase III, International, Multi-center, Randomized, Controlled, Open-label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Patients With Previously Untreated Follicular Lymphoma Followed by Maintenance Treatment With Either Rituximab SC or Rituximab IV
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.