An Observational Study of MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in First-Line in Patients With Diffuse Large B-Cell Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01724294
First received: November 7, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This multicenter, observational study will evaluate the correlation between clin ical and biological factors and International Prognostic Index (IPI) as prognost ic factors in patients with diffuse large B-cell lymphoma receiving first-line t reatment with MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy Eligible patients receiving treatment according to standard of care and local guidelines will be followed for the duration of treatment (approximately 8 month s) and during 1 year of follow-up.


Condition
Lymphoma, B-Cell

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional, Post-marketing Study to Evaluate the Correlation Between Clinical and Biological Factors and IPI as Prognostic Factors in Patients With DLBCL in First Line Treatment With R-CHOP

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Treatment patterns in clinical practice: Number of treatment cycles received [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Event-free survival [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Response rates [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: December 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (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 diffuse large B-cell lymphoma treated in first line with R-CHOP

Criteria

Inclusion Criteria:

  • Adult patients, >18 years of age
  • Patients with diagnosed diffuse large B-cell lymphoma in first-line treatment with R-CHOP

Exclusion Criteria:

  • Prior chemotherapy treatment for diffuse large B-cell lymphoma
  • Contra-indications or exclusion criteria according to the Summary of Product Characteristics for MabThera/Rituxan
  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: NCT01724294

Contacts
Contact: Reference Study ID Number: ML28497 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Romania
Recruiting
Bucuresti, Romania, 030171
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: NCT01724294     History of Changes
Other Study ID Numbers: ML28497
Study First Received: November 7, 2012
Last Updated: August 4, 2014
Health Authority: Romania: National Agency for Medicines and Medical Devices

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

ClinicalTrials.gov processed this record on September 18, 2014