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Positron Emission Tomography (PET)-Scan in the Evaluation of High Tumor Burden Follicular Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Lymphoma Study Association.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Lymphoma Study Association
ClinicalTrials.gov Identifier:
NCT00915096
First received: June 4, 2009
Last updated: March 14, 2010
Last verified: March 2010
  Purpose

The purpose of the study is to assess in a prospective series of patients with high tumor burden follicular lymphoma treated with R-CHOP, the predictive value of [18F]-FDG PET performed over (after 4 treatments), and at the end of the first-line treatment on progression-free survival at 2 years.


Condition
Lymphoma, Follicular

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: High Tumor Burden Follicular Lymphoma: Impact of [18F]-FDG Positron Emission Tomography (PET) in the Assessment of Treatment Response

Resource links provided by NLM:


Further study details as provided by Lymphoma Study Association:

Primary Outcome Measures:
  • Predictive value of PET on progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of PET results to treatment response (Cheson criteria) [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
  • Correlation of PET data with FLIPI index score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Comparison of changes in lymph node volumes measured by CT to changing of FDG fixation [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
  • Correlation of PET data with histopathological data (including the use of immunohistochemical markers) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Evaluation of the sensitivity of PET in the detection of the involvement of hematopoietic marrow [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Comparison of conventional criteria for evaluating the response to the criteria "revised" by the international workshop criteria [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Burden tissue sample


Estimated Enrollment: 120
Study Start Date: September 2007
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
High Tumor Burden Follicular Lymphoma

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

High Tumor Burden Follicular Lymphoma patients

Criteria

Inclusion Criteria:

  • Patients with malignant non-Hodgkin follicular lymphoma (histologic grade 1 to 3 in the WHO classification), histologically confirmed,
  • Patients who have not previously been treated for this disease,
  • Introducing one of the criteria for high tumor burden,
  • Patients aged over 18 and under 80 years,
  • Patients whose ECOG condition is ≤ 2,
  • Patients whose haematological functions are adequate within 28 days preceding the treatment (Hemoglobin ≥8,0g/dl; Neutrophils ≥1,5e-9/L, Platelets ≥100e-9/L),
  • Patient had the PET examination less than a month before the start of chemotherapy.

Exclusion Criteria:

  • Patients with lymphoma who have already transformed or been treated for this disease,
  • Patients whose lymphoma is stage 3b,
  • Patients with impaired central nervous system,
  • Patients regularly taking corticosteroids during the 4 weeks preceding the treatment (unless the dose administered is equivalent to ≤20 mg/day prednisone).
  • Patients who have undergone major surgery during the 28 days preceding the inclusion,
  • Patients with low kidney and/or liver function,
  • Patients with HIV + or had an infection with HBV or HCV less than 4 weeks. Patients with hepatitis B serology is positive unless the sign is related to vaccination,
  • Patients whose life expectancy ≤ 6 months,
  • Patients sensitive or allergic to murine products,
  • Patients who participated in another clinical trial during the 30 days preceding the recording,
  • Patients with other medical problems or psychological succeptibles interfere with the study,
  • Patients under adult supervision.
  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: NCT00915096

Locations
France
CHU - Besançon
Besançon, France
CHU Avicenne
Bobigny, France
Centre Bergognié
Bordeaux, France
Hôpital Henri Mondor
Créteil, France
CHU de Dijon
Dijon, France, 21034
Clinique Victor Hugo
Le Mans, France
Centre Hospitalier - Lens
Lens, France
CHRU Lille
Lille, France, 59037
CHU - Limoges
Limoges, France
Centre Paoli-Calmettes
Marseille, France
CHU - Nantes
Nantes, France
Hôpital Necker
Paris, France
Hôpital Pitié-Salpêtrière
Paris, France
Hôpital Saint-Louis
Paris, France
CHU Lyon Sud
Pierre Benite, France, 69310
CHU Robert Debré
Reims, France
Centre Henri Becquerel
Rouen, France, 76038
CHU Purpan
Toulouse, France
Hôpital Bretonneau
Tours, France
CHU Brabois
Vandoeuvre les Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France
Italy
Ospedale Cuneo
Cuneo, Italy
Sponsors and Collaborators
Lymphoma Study Association
Investigators
Principal Investigator: Michel MEIGNAN, Prof Lymphoma Study Association
Principal Investigator: Jehan DUPUIS, MD Lymphoma Study Association
  More Information

Additional Information:
GELA  This link exits the ClinicalTrials.gov site

No publications provided by Lymphoma Study Association

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Michel MEIGNAN, CHU Henri MONDOR
ClinicalTrials.gov Identifier: NCT00915096     History of Changes
Other Study ID Numbers: PET-FOL, PRC06002
Study First Received: June 4, 2009
Last Updated: March 14, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Lymphoma Study Association:
Follicular Lymphoma
PET
GELA

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014