An Observational Study of MabThera/Rituxan (Rituximab) Plus Chemotherapy As First-Line Treatment in Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma

This observational study will evaluate the safety and efficacy of MabThera/Rituxan (rituximab) plus chemotherapy as first-line treatment in patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL). Data will be collected from each patient during the 6 months of induction treatment and for up to 3 years of follow-up.

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Key information

Conditions

Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA), Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Histologically confirmed CD20+ diffuse large B-cell lymphoma or follicular lymphoma
Treatment with MabThera/Rituxan as per locally approved China package insert
Documented patient with medical records

Exclusion criteria

Previous treatment for diffuse large B-cell lymphoma or follicular lymphoma

Treatment and study plan

Primary outcomes

Safety: Incidence of adverse events

Time frame: 4.5 years

Secondary outcomes

Overall Response Rate (complete response + partial response)

Time frame: 4.5 years
Progression-free survival, defined as time from first treatment to lymphoma progression or death

Time frame: 4.5 years
Overall Survival, defined as time from 1st treatment to death of any cause

Time frame: 4.5 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Multi Centre, Single Arm, Observational Study on Safety and Efficacy of MabThera Plus Chemotherapy as 1st Line Treatment in Patients With DLBCL or FL

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Apr 22, 2011
Registry last updated: Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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