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

NCT01715961 | Completed DMC

• 1 other identifier: CHB 11-02
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B Cell Lymphoma; Grade IIIB Follicular Lymphoma

Keywords

70 years old; DLBCL; Rituximab-CHOP; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• progression free survival

  at 18 months

Secondary Outcomes (3)

• 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

Study Arms (1)

anthropometric measurement

OTHER

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

Procedure: anthropometric measurement

Interventions

anthropometric measurement PROCEDURE

To attest the muscular strength: hand grip test, balance test, up and go test

Also known as: Hand Grip strength test, Timed get up and go test

anthropometric measurement

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• Signed informed consent

You may not qualify if:

• Positivity for HCV, HBV and HIV
• Anthracycline contra-indication

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (1)

Centre Henri Becquerel

Rouen, 76000, France

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Sarcopenia

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Fabrice JARDIN, MD;PhD

  Centre Henri Becquerel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: October 29, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: August 1, 2016
• Last Updated: October 5, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)