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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00930514
First Posted: June 30, 2009
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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: Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Area Under the Curve From Time Zero to end of Dosing Interval (AUCtau) [ Time Frame: Up to 29 months ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to 29 months ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Up to 29 months ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: Up to 29 months ]
  • Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Up to 29 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: June 16, 2009
First Posted: June 30, 2009
Last Update Posted: November 2, 2016
Last Verified: November 2016

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