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
• Interventions: Procedure: anthropometric measurement

• 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

Arm && Interventions

Group	Intervention	Description
anthropometric measurement	anthropometric measurement	The muscle area assessed by CT scan imaging at a lumbar vertebral landmark (L3) at the time of diagnosis, at the end of treatment, at 12 and 18 months * anthropometric measures (weight, height, BMI, brachial and calf circumference) and MNA (mini nutritional assessment) * albuminemia, transthyretin, orosomucoid, CRP * functional test to attest the muscular strength: hand grip test, unipodal test, up and go test * hematological and non-hematological chemotherapy toxicities of cycle 1 and cycle 2 * OS and PFS at 18 and 24 months * GCB and ABC phenotypes determined by immunohistochemistry and transcriptome analysis

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