Multicentric Prospective Study to Assess the Clinical and Prognostic Value of Sarcopenia in Patients Older Than 70 Years With Diffuse Large B-cell Lymphoma

Centre Henri Becquerel1 site in 1 country98 target enrollmentJanuary 2012

ConditionsDiffuse Large B Cell Lymphoma Grade IIIB Follicular Lymphoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diffuse Large B Cell Lymphoma
Sponsor: Centre Henri Becquerel
Enrollment: 98
Locations: 1
Primary Endpoint: progression free survival
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This clinical trial is a multicentric prospective study to assess the clinical and prognostic value of sarcopenia in patients older than 70 years with diffuse large B-cell lymphoma.

Detailed Description

Sarcopenia status is assessed by CT scan imaging on the overall survival at 18 months in patients older than 70 years with diffuse large B-cell lymphoma treated by R-CHOP.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

August 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre Henri Becquerel

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients \>= 70 years
•DLBCL, grade IIIB follicular lymphoma or histologically proven transformed low grade lymphoma
•Whatever the IPI score and the performance status
•Treated by Rituximab-CHOP or Rituximab-mini-CHOP
•CT scan imaging performed one month or less before inclusion
•Signed informed consent

Exclusion Criteria

•No initial CT scan imaging performed more than one month before inclusion
•Positivity for HCV, HBV and HIV
•Anthracycline contra-indication

Outcomes

Primary Outcomes

progression free survival

Time Frame: at 18 months

Secondary Outcomes

progression free survival(at 24 months)
rate of over grade 2 toxicities(at the first and second courses of chemotherapy (day 21 and day 42))
determination of both molecular subtypes GCB and ABC(at 24 months)