A Study of MabThera (Rituximab) Subcutaneous Vs. MabThera (Rituximab) Intravenous in Patients With Follicular Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01200758
First received: September 10, 2010
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This two-stage, multi-center, randomized, controlled, open-label study will inve stigate the pharmacokinetics, efficacy and safety of MabThera (rituximab) subcut aneous versus MabThera (rituximab) intravenous in patients with previously untre ated follicular non-Hodgkin's lymphoma. Patients will be randomized to receive 3 75 mg/m² MabThera as intravenous infusion or 1400 mg MabThera given subcutaneous ly. In addition, patients will receive standard chemotherapy. Patients who achie ved a complete or partial response after 8 treatment cycles, will receive mainte nance 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.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: MabThera subcutaneous
Drug: Mabthera intravenous
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Stage II: To estimate the overall response rate in each treatment arm at the end of induction treatment [ Time Frame: Week 24 (Cycle 8) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: 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 [ Time Frame: Week 24 (Cycle 8) ] [ Designated as safety issue: 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 [ Time Frame: Week 24 (Cycle 8) ] [ Designated as safety issue: No ]
  • To compare peripheral blood B-cell depletion and repletion after MabThera subcutaneous and MabThera intravenous treatment [ Time Frame: 96 weeks ] [ Designated as safety issue: 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 [ Time Frame: Week 24 (cycle 8) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: 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 [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • To compare the safety profiles of MabThera subcutaneous and MabThera intravenous [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • To compare the immunogenicity of MabThera subcutaneous and MabThera intravenous [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • To compare observed MabThera serum Ctrough levels during induction treatment [ Time Frame: Week 24 (Cycle 8) ] [ Designated as safety issue: No ]
  • To compare observed MabThera serum Ctrough levels during maintenance treatment [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Enrollment: 410
Study Start Date: February 2011
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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.
Experimental: 2 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200758

  Show 150 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01200758     History of Changes
Other Study ID Numbers: BO22334, 2010-021377-36
Study First Received: September 10, 2010
Last Updated: August 26, 2014
Health Authority: To: be added

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 27, 2014