An Observational Study of First-Line Maintenance MabThera/Rituxan (Rituximab) in Patients With Follicular Non-Hodgkin's Lymphoma

This study is currently recruiting participants.
Verified April 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01684865
First received: September 11, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This prospective observational study will evaluate the safety and efficacy of first-line MabThera/Rituxan (rituximab) maintenance therapy in patients with follicular non-Hodgkin's lymphoma. Patients initiated on MabThera/Rituxan maintenance therapy according to the standard of care and in line with the current summary of product characteristics will be followed for a maximum of two years or until disease progression occurs.


Condition
Non-Hodgkin's Lymphoma, Lymphoma, Follicular

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Event free rate [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with follicular non-Hodgkin's lymphoma receiving first-line Rituximab maintenance treatment

Criteria

Inclusion Criteria:

  • Adult patients (according to local regulation)
  • Patients receiving first-line MabThera/Rituxan maintenance treatment for follicular non-Hodgkin's lymphoma according to the local label and who give consent to take part within 4 weeks after commencing treatment

Exclusion Criteria:

  • Contraindications according to the Summary of Product Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684865

Contacts
Contact: Reference Study ID Number: ML27993 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Macedonia, The Former Yugoslav Republic of
Recruiting
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
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: NCT01684865     History of Changes
Other Study ID Numbers: ML27993
Study First Received: September 11, 2012
Last Updated: April 7, 2014
Health Authority: Macedonia: Ministry of Health Pharmaceuticals Bureau

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014