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Health Condition(s) or Problem
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Non-Hodgkin's Lymphoma
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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Drug; 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.; 1; Drug; 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.; 2
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Primary aim
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Stage I: To estimate the ratio of trough serum concentrations of MabThera after subcutaneous administration to that obtained after intravenous administration; Stage II: To estimate the overall response rate in each treatment arm at the end of induction treatment
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Secondary Aim
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Stage I: To compare observed MabThera serum concentrations (MabThera intravenous vs. subcutaneous) during induction treatment given every 3 weeks; Week 24 (Cycle 8); No; 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; Week 24 (Cycle 8); No; 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; Week 24 (Cycle 8); No; To compare peripheral blood B-cell depletion and repletion after MabThera subcutaneous and MabThera intravenous treatment; 96 weeks; No; To compare complete response rates of MabThera subcutaneous and MabThera intravenous given in combination with chemotherapy at the end/completion of the induction treatment; Week 24 (cycle 8); No; To compare overall response rate and complete response rate of MabThera subcutaneous and MabThera intravenous at the end/completion of maintenance treatment; 96 weeks; No; 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; 96 weeks; No; To compare the safety profiles of MabThera subcutaneous and MabThera intravenous; 96 weeks; No; To compare the immunogenicity of MabThera subcutaneous and MabThera intravenous; 96 weeks; No; To compare observed MabThera serum Ctrough levels during induction treatment; Week 24 (Cycle 8); No; To compare observed MabThera serum Ctrough levels during maintenance treatment; 96 weeks; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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Scotland, England
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Location
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Dundee, London, Maidstone, Plymouth, Romford, Southampton, Wakefield, Wolverhampton
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