Clinical and Prognostic Value of Sarcopenia in Patients Older Than 70 Years With Diffuse Large B-cell Lymphoma

Not Applicable

Completed

• Conditions: Diffuse Large B Cell Lymphoma; Grade IIIB Follicular Lymphoma

• Registration Number: NCT01715961
• Lead Sponsor: Centre Henri Becquerel

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-04-11
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-29
• Primary Completion: 2015-12
• Status Verified: 2016-07
• Study Completion: 2016-08
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
progression free survival	at 18 months

Secondary Outcome Measures

Name	Time	Method
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	according DASL technology (c-DNA mediated annealing selection extension and ligation)

Trial Locations

Locations (1)

Centre Henri Becquerel; 🇫🇷 Rouen, France