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
Recruitment status was Active, not recruiting
Sponsor:
Lymphoma Study Association
Information provided by:
Lymphoma Study Association
ClinicalTrials.gov Identifier:
NCT00915096
First received: June 4, 2009
Last updated: March 14, 2010
Last verified: March 2010
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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
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 Pitié-Salpêtrière | |
| Paris, France | |
| Hôpital Necker | |
| 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 
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 Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |
ClinicalTrials.gov processed this record on May 22, 2013