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

Centre Henri Becquerel

Status: Completed

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

Treatments: Procedure: anthropometric measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT01715961

CHB 11-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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98 participants in 1 patient group

anthropometric measurement

Other group

Description:

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

Treatment:

Procedure: anthropometric measurement