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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01724294
Recruitment Status : Terminated
First Posted : November 9, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This multicenter, observational study will evaluate the correlation between clinical and biological factors and International Prognostic Index (IPI) as prognostic factors in patients with diffuse large B-cell lymphoma receiving first-line treatment 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 months) and during 1 year of follow-up.

Condition or disease
Diffuse Large B-Cell Lymphoma

Study Type : Observational
Actual Enrollment : 113 participants
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
Study Start Date : December 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources


Primary Outcome Measures :
  1. Treatment patterns in clinical practice: Number of treatment cycles received [ Time Frame: approximately 4 years ]

Secondary Outcome Measures :
  1. Event-free survival [ Time Frame: approximately 4 years ]
  2. Response rates [ Time Frame: approximately 4 years ]
  3. Safety: Incidence of adverse events [ Time Frame: approximately 4 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with diffuse large B-cell lymphoma treated in first line with R-CHOP

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01724294

Bucuresti, Romania, 030171
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01724294     History of Changes
Other Study ID Numbers: ML28497
First Posted: November 9, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

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