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

Diffuse Large B Cell Lymphoma Clinical Trial

— SARCOPENIE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715961
• Other study ID #: CHB 11-02
• Status: Completed
• Phase: N/A
• First received: April 11, 2012
• Last updated: October 4, 2016
• Start date: January 2012
• Est. completion date: August 2016

Study information

• Verified date: July 2016
• Source: Centre Henri Becquerel
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: August 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Grade IIIB Follicular Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Follicular
• Lymphoma, Large B-Cell, Diffuse
• Sarcopenia

Intervention

Procedure:
• anthropometric measurement
To attest the muscular strength: hand grip test, balance test, up and go test

Locations

Country	Name	City	State
France	Centre Henri Becquerel	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		at 18 months	No
Secondary	progression free survival		at 24 months	No
Secondary	rate of over grade 2 toxicities		at the first and second courses of chemotherapy (day 21 and day 42)	No
Secondary	determination of both molecular subtypes GCB and ABC	according DASL technology (c-DNA mediated annealing selection extension and ligation)	at 24 months	No