Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00930514
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE June 16, 2009
First Posted Date  ICMJE June 30, 2009
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE September 2009
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2015)
Minimum Observed Plasma Trough Concentration (C trough) [ Time Frame: Up to 29 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 29, 2009)
C trough [ Time Frame: At intervals up to day 84 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2009)
  • AUC 0-last, Cmax, tmax, t1/2 [ Time Frame: At intervals up to day 84 ]
  • Adverse events, laboratory parameters [ Time Frame: Throughout study, at each clinic visit ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pharmacokinetic Study of Subcutaneous and Intravenous Rituximab in Participants With Follicular Lymphoma
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, Follicular
Intervention  ICMJE
  • 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
  • Drug: Rituximab
    Rituximab subcutaneous injection 625 mg/m^2 administered every 2 or 3 months.
    Other Name: MabThera/Rituxan
  • Drug: Rituximab
    Rituximab intravenous infusion 375 milligram per square meter (mg/m^2) administered every 2 or 3 months.
    Other Name: MabThera/Rituxan
  • Drug: Rituximab
    Rituximab subcutaneous injection 375 mg/m^2 administered every 2 or 3 months.
    Other Name: MabThera/Rituxan
Study Arms  ICMJE
  • Active Comparator: Rituximab IV 375 mg/m^2 (Stage 1: Cohort A)
    Intervention: Drug: Rituximab
  • Active Comparator: Rituximab IV 375 mg/m^2 (Stage 2: Cohort E)
    Intervention: Drug: Rituximab
  • Experimental: Rituximab SC 1400 mg (Stage 2: Cohort F)
    Interventions:
    • Drug: Rituximab
    • Drug: Rituximab
  • Experimental: Rituximab SC 375 mg/m^2 (Stage 1: Cohort B)
    Intervention: Drug: Rituximab
  • Experimental: Rituximab SC 625 mg/m^2 (Stage 1: Cohort C)
    Intervention: Drug: Rituximab
  • Experimental: Rituximab SC 800 mg/m^2 (Stage 1: Cohort D)
    Intervention: Drug: Rituximab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2012)
281
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2009)
245
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Canada,   Czech Republic,   Denmark,   Ecuador,   Finland,   France,   Israel,   Italy,   Korea, Republic of,   Mexico,   Norway,   Peru,   Poland,   Russian Federation,   Slovakia,   Spain,   Sweden,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00930514
Other Study ID Numbers  ICMJE BP22333
2008-008490-60
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP