A Pharmacokinetic Study of Subcutaneous and Intravenous MabThera (Rituximab) in Patients 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: August 4, 2014
Last verified: August 2014
  Purpose

This 2 stage study will compare the pharmacokinetics and safety profile of subcu taneous and intravenous MabThera (rituximab) in patients with follicular lymphom a.In the first stage, patients who have achieved at least a partial response aft er 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 pharm acokinetics evaluated on an ongoing basis. Upon selection of the sc dose which r esults in rituximab C trough values comparable to those achieved with the iv for mulation, patients in the second stage of the study will be randomized to receiv e either the sc or iv formulation to demonstrate comparability of the C trough l evels with both routes of administration. Maintenance therapy will continue ever y 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:


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
Study Completion Date: July 2013
Primary Completion Date: July 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
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

No publications provided by Hoffmann-La Roche

Additional 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: August 4, 2014
Health Authority: Ecuador: Public Health Ministry

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

ClinicalTrials.gov processed this record on August 19, 2014