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

Purpose

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.

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

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab

U.S. FDA Resources

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 ]

Estimated Enrollment:	530
Study Start Date:	February 2011
Estimated Study Completion Date:	April 2019
Estimated Primary Completion Date:	April 2019 (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

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

Contacts

Contact: Please reference Study ID Number: BO22334 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Show 150 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

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:	May 7, 2013
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
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 18, 2013