A Study of MabThera (Rituximab) Subcutaneous Vs. MabThera (Rituximab) Intravenous in Patients With Follicular Non-Hodgkin's Lymphoma | Not Recruiting
A Study of MabThera (Rituximab) Subcutaneous Vs. MabThera (Rituximab) Intravenous in Patients With Follicular Non-Hodgkin's Lymphoma
Health Conditions
  • Non-Hodgkin's Lymphoma
Not Recruiting
Recruitment Status
NCT01200758
Primary Trial ID Number
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.
Primary Outcome Measures
  • Stage I: To estimate the ratio of trough serum concentrations of MabThera after subcutaneous administration to that obtained after intravenous administration; Day 21; Stage II: To estimate the overall response rate in each treatment arm at the end of induction treatment; Week 24 (Cycle 8)
Secondary Outcome Measures
  • Stage I: To compare observed MabThera serum concentrations (MabThera intravenous vs. subcutaneous) during induction treatment given every 3 weeks; 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; 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; Week 24 (Cycle 8); To compare peripheral blood B-cell depletion and repletion after MabThera subcutaneous and MabThera intravenous treatment; 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; 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; 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; 96 weeks; To compare the safety profiles of MabThera subcutaneous and MabThera intravenous; 96 weeks; To compare the immunogenicity of MabThera subcutaneous and MabThera intravenous; 96 weeks; To compare observed MabThera serum Ctrough levels during induction treatment; Week 24 (Cycle 8); To compare observed MabThera serum Ctrough levels during maintenance treatment; 96 weeks
Research Question
  • 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.
Design Type
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Ethics Approval
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Publications
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Countries of Recruitment
Australia; Belgium; Bosnia and Herzegovina; Brazil; Bulgaria; Canada; Colombia; Croatia; Denmark; Finland; France; Georgia; Germany; Greece; Italy; Macedonia, The Former Yugoslav Republic of; Malaysia; Mexico; New Zealand; Peru; Romania; Russian Federation; Serbia; Singapore; Slovakia; South Africa; Spain; Thailand; Turkey; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
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Trial Sample Size
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Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
  • 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
Interventions
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]; 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]
Design Details
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Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific 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
Secondary Trial Identifying Number
2010-021377-36
Website
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Study Funded By
Hoffmann-La Roche
Funder Type
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Study Sponsored By
Hoffmann-La Roche
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

10 Sep 2010

Last Updated

02 Apr 2015

Date Record Refreshed on UKCTG

31 Jul 2015