A Pharmacokinetic Study of Subcutaneous and Intravenous Rituximab in Participants With Follicular Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00930514
First received: June 16, 2009
Last updated: April 2, 2016
Last verified: April 2016
  Purpose
This 2 stage study will compare the pharmacokinetics and safety profile of subcutaneous and intravenous rituximab in participants with follicular lymphoma. In the first stage, participants who have achieved at least a partial response after induction treatment with intravenous rituximab will be randomized to one of 3 treatment cohorts, to receive rituximab 375 milligram per square meter (mg/m^2) intravenously, 375 mg/m^2 subcutaneously or 625 mg/m^2 subcutaneously, and pharmacokinetics evaluated on an ongoing basis. Upon selection of the subcutaneous dose (800 mg/m^2) which results in rituximab trough plasma concentration (C trough) values comparable to those achieved with the intravenous formulation, participants in the second stage of the study will be randomized to receive either the subcutaneous or intravenous formulation to demonstrate comparability of the C trough levels with both routes of administration. Maintenance therapy will continue every 2 or 3 months with the subcutaneous formulation.

Condition Intervention Phase
Lymphoma, Follicular
Drug: Rituximab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Two Stage Phase Ib Study to Investigate the Pharmacokinetics, Safety and Tolerability of Rituximab Subcutaneous (SC) Formulation in Patients With Follicular Lymphoma (FL) as Part of Maintenance Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Minimum Observed Plasma Trough Concentration (C trough) [ Time Frame: Up to 29 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area Under the Curve From Time Zero to end of Dosing Interval (AUCtau) [ Time Frame: Up to 29 months ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to 29 months ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Up to 29 months ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: Up to 29 months ] [ Designated as safety issue: No ]
  • Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Up to 29 months ] [ Designated as safety issue: No ]

Enrollment: 281
Study Start Date: September 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rituximab IV 375 mg/m^2 (Stage 1: Cohort A) Drug: Rituximab
Rituximab intravenous infusion 375 milligram per square meter (mg/m^2) administered every 2 or 3 months.
Other Name: MabThera/Rituxan
Active Comparator: Rituximab IV 375 mg/m^2 (Stage 2: Cohort E) Drug: Rituximab
Rituximab intravenous infusion 375 milligram per square meter (mg/m^2) administered every 2 or 3 months.
Other Name: MabThera/Rituxan
Experimental: Rituximab SC 1400 mg (Stage 2: Cohort F) Drug: Rituximab
Rituximab subcutaneous injection at 1400 mg dose level, administered every 2 or 3 months.
Drug: Rituximab
Rituximab subcutaneous injection at 800 mg/m^2 dose level, administered every 2 or 3 months.
Other Name: MabThera/Rituxan
Experimental: Rituximab SC 375 mg/m^2 (Stage 1: Cohort B) Drug: Rituximab
Rituximab subcutaneous injection 375 mg/m^2 administered every 2 or 3 months.
Other Name: MabThera/Rituxan
Experimental: Rituximab SC 625 mg/m^2 (Stage 1: Cohort C) Drug: Rituximab
Rituximab subcutaneous injection 625 mg/m^2 administered every 2 or 3 months.
Other Name: MabThera/Rituxan
Experimental: Rituximab SC 800 mg/m^2 (Stage 1: Cohort D) Drug: Rituximab
Rituximab subcutaneous injection at 800 mg/m^2 dose level, administered every 2 or 3 months.
Other Name: MabThera/Rituxan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CD20-positive follicular non-Hodgkin's lymphoma (NHL)
  • Documented partial or complete response a the end of induction treatment with rituximab
  • Must have completed induction treatment, and received at least 1 dose of intravenous rituximab maintenance treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than and equal to (<=) 2
  • Life expectancy of greater than and equal to (>=) 6 months

Exclusion Criteria:

  • Histological evidence of transformation of NHL, or types of NHL other than follicular lymphoma
  • Presence or history of central nervous system disease
  • History of malignancy other than follicular NHL
  • Recent major surgery (within 4 weeks prior to screening), excluding lymph node biopsy
  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: NCT00930514

  Show 62 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00930514     History of Changes
Other Study ID Numbers: BP22333  2008-008490-60 
Study First Received: June 16, 2009
Last Updated: April 2, 2016
Health Authority: Ecuador: Public Health Ministry

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

ClinicalTrials.gov processed this record on May 03, 2016