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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00930514
First received: June 16, 2009
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Lymphoma, Follicular
 Drug: rituximab [MabThera/Rituxan]
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Two Stage Phase Ib Study to Investigate the Pharmocokinetics and Tolerability of Rituximab Subcutaneous Formulation in Pats With Follicular Lymphoma as Part of Maintenance Treatement.

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:
  • C trough [ Time Frame: At intervals up to day 84 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 281
Study Start Date: September 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cohort 1 (Part 1) Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv single dose
Experimental: Cohort 2 (Part 1) Drug: rituximab [MabThera/Rituxan]
375mg/m2 sc single dose
Experimental: Cohort 3 (Part 1) Drug: rituximab [MabThera/Rituxan]
625mg/m2 sc single dose
Active Comparator: Cohort 1 (Part 2) Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv single dose
Experimental: Cohort 2 (Part 2) Drug: rituximab [MabThera/Rituxan]
Optimal dose sc from Part 1

  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 (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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930514

  Show 60 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: NCT00930514     History of Changes
Other Study ID Numbers: BP22333, 2008-008490-60
Study First Received: June 16, 2009
Last Updated: May 7, 2013
Health Authority: Ecuador: Public Health Ministry

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
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013