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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Non-Hodgkin's Lymphoma
Unfortunately contact details are not available for this trial.
Primary Contact Details
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.
Research Details
  • This is a two-stage study. Stage 1 was designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3 weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1. Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with rituximab IV.
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : MabThera subcutaneous, Drug : Mabthera intravenous, Drug : Standard Chemotherapy

Study Arm Groups : 2, 1, 1, 2

Intervention Type
See Interventions above
Primary Outcome Measures
  • Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab; Stage I: Cycle 7 Day 21 (within 2 hours pre-dose on Cycle 8) of induction treatment; Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment; Stage II: up to end of induction treatment Cycle 8 (24 weeks); Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Induction Treatment; Stage I and II: Baseline up to end of induction treatment Cycle 8 (24 weeks)
Secondary Outcome Measures
  • Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment; Stage I: up to end of induction treatment Cycle 8 (24 weeks); Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment; Stage I: up to end of induction treatment Cycle 8 (24 weeks); Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment; Stage II: up to end of induction treatment Cycle 8 (24 weeks); Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Induction Treatment; Stage I and II: Baseline up to end of induction treatment Cycle 8 (24 weeks); Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Maintenance Treatment; Stage I and Stage II: up to 78 days after last maintenance dose (last maintenance dose: maintenance Cycle 12/Study Cycle 20 [30 months]); Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Maintenance Treatment; Stage I and II: up to 78 days after last maintenance dose (last maintenance dose: maintenance Cycle 12/Study Cycle 20 [30 months]); Stage 1 and II (Pooled): Progression-Free Survival (PFS); Baseline, Day 1 of all cycles (Cycles 1-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 3 February 2014); Percentage of Participants With Disease Progression or Death; Baseline, Day 1 of all cycles (Cycles 1-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 3 February 2014); Stage I and II (Pooled): Event-Free Survival; Baseline until documented disease progression/relapse or death (up to study completion); Stage I and II (Pooled): Median Time to Overall Survival (OS); Baseline until documented disease progression/relapse or death (up to study completion); Stage 1: Observed Area Under the Serum Concentration-Time Curve (AUC) of IV and SC Rituximab at Week 7; Stage I (Induction): pre-dose and 24 hours post-dose on Cycle 7 (Days 1, 3, 7, and 15), pre-dose on Cycle 8 Day 1; additionally within 15 minutes after end of infusion on Cycle 7 Day 1 for rituximab IV (up to data cutoff of 11 April 2012); Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab at Cycle 7; Stage I (Induction): pre-dose and 24 hours post-dose on Cycle 7 (Days 1, 3, 7, and 15), pre-dose on Cycle 8 Day 1; additionally within 15 minutes after end of infusion on Cycle 7 Day 1 (up to cutoff date of 11 April 2012); Stage I and II (Pooled): Trough Serum Concentrations (Ctrough) of Rituximab at Each Induction Treatment Cycle; C-trough values are based upon samples scheduled 21 days after study drug administration (before the next scheduled cycle), except for cycle 8 which were scheduled 28 days after drug administration.; Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle; C-trough values are based upon samples scheduled before each maintenance Cycle 9 to 20 (maintenance Cycle 1 to 12). i.e. 'Cycle 8' and 'Cycle 19' are before the first and last maintenance administration at 'Cycle 9' and 'Cycle 20', respectively.; Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration; 12 weeks, 24 weeks, and 36 weeks after the last rituximab administration (median treatment duration: 383.5 days for IV dose and 406 days for SC dose; up to data cutoff of 3 February 2014); Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase; Stage I and II (induction): for rituximab IV - Day 1 of Cycle 1 to 8; for rituximab SC - Day 1 of Cycle 1 and Cycle 3 to 8, Day 0 of Cycle 2, thereafter at follow-up visits every 12 weeks after the last rituximab administration until 72 weeks; Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase; Stage I and II (maintenance): Day 1 of Cycle 9 to 20 (up to data cutoff of 3 February 2014); Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Chimeric Antibodies (HACAs); Baseline, Post-Baseline (Cycle 1 Day 1 [induction] up to follow-up) (a median of 27 months; up to data cutoff of 3 February 2014)
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
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
This is in the inclusion criteria above
Trial Location(s)
Derriford Hospital
Plymouth
England
PL6 8DH
Southampton General Hospital
Southampton
England
SO16 6YD
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone
England
ME16 9QQ
Research Site
Dundee
DD1 9SY
New Cross Hospital
Wolverhampton
Midlands
WV10 0QP
Pinderfields Hospital
Wakefield
WF1 4DG
Receptos Study Site 966
Romford
RM7 0AG
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
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
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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
BO22334
Sponsor(s)
Hoffmann-La Roche
Key Dates

Recruitment Start Date

Feb 2011

Recruitment End Date

Nov 2017

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

10 Sep 2010

Last Updated

07 Aug 2015