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

This study is currently recruiting participants.
Verified April 2014 by Centre Henri Becquerel
Sponsor:
Information provided by (Responsible Party):
Centre Henri Becquerel
ClinicalTrials.gov Identifier:
NCT01715961
First received: April 11, 2012
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Diffuse Large B Cell Lymphoma
Grade IIIB Follicular Lymphoma
Procedure: anthropometric measurement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Centre Henri Becquerel:

Primary Outcome Measures:
  • progression free survival [ Time Frame: at 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression free survival [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
  • rate of over grade 2 toxicities [ Time Frame: at the first and second courses of chemotherapy (day 21 and day 42) ] [ Designated as safety issue: No ]
  • determination of both molecular subtypes GCB and ABC [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
    according DASL technology (c-DNA mediated annealing selection extension and ligation)


Estimated Enrollment: 96
Study Start Date: January 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: anthropometric measurement
To attest the muscular strength: hand grip test, balance test, up and go test
Other Names:
  • Hand Grip strength test
  • Timed get up and go test

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715961

Contacts
Contact: Fabrice JARDIN, M.D., Ph.D 2 32 08 29 09 ext 33 fabrice.jardin@chb.unicancer.fr
Contact: Helene LANIC, M.D. 2 32 08 29 1409 ext 33 helene.lanic@chb.unicancer.fr

Locations
France
Centre Henri Becquerel Recruiting
Rouen, France, 76000
Contact: Sandrine VAUDAUX, CRA    2 32 08 24 96 ext 33    sandrine.vaudaux@chb.unicancer.fr   
Sub-Investigator: Helene LANIC, MD         
Principal Investigator: Fabrice JARDIN, MD; Ph.D         
Sponsors and Collaborators
Centre Henri Becquerel
Investigators
Study Director: Fabrice JARDIN, MD;PhD Centre Henri Becquerel
  More Information

No publications provided

Responsible Party: Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT01715961     History of Changes
Other Study ID Numbers: CHB 11-02
Study First Received: April 11, 2012
Last Updated: April 8, 2014
Health Authority: France: Ministry of Health

Keywords provided by Centre Henri Becquerel:
70 years old
DLBCL
Rituximab-CHOP
Sarcopenia

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Sarcopenia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014