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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Henri Becquerel
ClinicalTrials.gov Identifier:
NCT01715961
First received: April 11, 2012
Last updated: April 18, 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: 98
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Centre Henri Becquerel
Rouen, France, 76000
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 18, 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, Non-Hodgkin
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
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014