A Pharmacokinetic Study of Subcutaneous and Intravenous MabThera (Rituximab) in Patients With Follicular Lymphoma

Tracking Information

Start Date  ICMJESeptember 2009
Primary Completion Date 
Current Primary Outcome Measures  ICMJE 
 (submitted: June 29, 2009)
C trough [ Time Frame: At intervals up to day 84 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00930514 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: June 29, 2009)
  • AUC 0-last, Cmax, tmax, t1/2 [ Time Frame: At intervals up to day 84 ] [ Designated as safety issue: No ]
  • Adverse events, laboratory parameters [ Time Frame: Throughout study, at each clinic visit ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Pharmacokinetic Study of Subcutaneous and Intravenous MabThera (Rituximab) in Patients With Follicular Lymphoma
Official Title  ICMJEA Two Stage Phase Ib Study to Investigate the Pharmacokinetics and Tolerability of Rituximab Subcutaneous Formulation in Pats With Follicular Lymphoma as Part of Maintenance Treatment.
Brief Summary

This 2 stage study will compare the pharmacokinetics and safety profile of subcutaneous and intravenous MabThera (rituximab) in patients with follicular lymphoma.In the first stage, patients who have achieved at least a partial response after induction treatment with iv MabThera will be randomized to one of 3 treatment cohorts, to receive MabThera 375mg/m2 iv, 375mg/m2 sc or 625mg/m2 sc, and pharmacokinetics evaluated on an ongoing basis. Upon selection of the sc dose which results in rituximab C trough values comparable to those achieved with the iv formulation, patients in the second stage of the study will be randomized to receive either the sc or iv 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 sc formulation. The anticipated time on study treatment is up to 31 months for an individual patient, and the target sample size is 215-250 individuals.

Detailed Description 
Study PhasePhase I
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Condition  ICMJEFollicular Lymphoma
Intervention  ICMJE
  • Drug: rituximab [MabThera/Rituxan]
    375mg/m2 iv single dose
  • Drug: rituximab [MabThera/Rituxan]
    375mg/m2 sc single dose
  • Drug: rituximab [MabThera/Rituxan]
    625mg/m2 sc single dose
  • Drug: rituximab [MabThera/Rituxan]
    Optimal dose sc from Part 1
Study Arms / Comparison Groups
  • Cohort 1 (Part 1): Active Comparator
    Intervention: Drug: rituximab [MabThera/Rituxan]
  • Cohort 2 (Part 1): Experimental
    Intervention: Drug: rituximab [MabThera/Rituxan]
  • Cohort 3 (Part 1): Experimental
    Intervention: Drug: rituximab [MabThera/Rituxan]
  • Cohort 1 (Part 2): Active Comparator
    Intervention: Drug: rituximab [MabThera/Rituxan]
  • Cohort 2 (Part 2): Experimental
    Intervention: Drug: rituximab [MabThera/Rituxan]

Recruitment Information

Estimated Enrollment  ICMJE245
Estimated Completion DateMay 2014
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • CD20-positive follicular non-Hodgkin's lymphoma (NHL);
  • partial or complete response a the end of induction treatment with MabThera;
  • must have completed induction treatment, and received >= 1 dose of iv MabThera maintenance treatment;
  • ECOG performance status of <=2.

Exclusion Criteria:

  • histological evidence of transformation of NHL, or types of NHL other han follicular lymphoma;
  • presence or history of CNS disease;
  • history of malignancy other than follicular NHL which could affect compliance with protocol or interpretation of results;
  • recent major surgery (within 4 weeks prior to screening, excluding lymph node biopsy).
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: BP22333888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJEArgentina,   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

Administrative Information

Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEBP22333, 2008-008490-60
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche