Lymphoma, Follicular Clinical Trial
Official title:
High Tumor Burden Follicular Lymphoma: Impact of [18F]-FDG Positron Emission Tomography (PET) in the Assessment of Treatment Response
NCT number | NCT00915096 |
Other study ID # | PET-FOL |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 18, 2007 |
Est. completion date | February 8, 2013 |
Verified date | August 2018 |
Source | Lymphoma Study Association |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 121 |
Est. completion date | February 8, 2013 |
Est. primary completion date | May 10, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | CHU - Besançon | Besançon | |
France | CHU Avicenne | Bobigny | |
France | Centre Bergognié | Bordeaux | |
France | Hôpital Henri Mondor | Créteil | |
France | CHU de Dijon | Dijon | |
France | Clinique Victor Hugo | Le Mans | |
France | Centre Hospitalier - Lens | Lens | |
France | CHRU Lille | Lille | |
France | 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 | CHU Robert Debré | Reims | |
France | Centre Henri Becquerel | Rouen | |
France | CHU Purpan | Toulouse | |
France | Hôpital Bretonneau | Tours | |
France | CHU Brabois | Vandoeuvre les Nancy | |
France | Institut Gustave Roussy | Villejuif | |
Italy | Ospedale Cuneo | Cuneo |
Lead Sponsor | Collaborator |
---|---|
Lymphoma Study Association |
France, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Predictive value of PET on progression-free survival | 2 years | ||
Secondary | Comparison of PET results to treatment response (Cheson criteria) | 30 weeks | ||
Secondary | Correlation of PET data with FLIPI index score | Baseline | ||
Secondary | Comparison of changes in lymph node volumes measured by CT to changing of FDG fixation | 30 weeks | ||
Secondary | Correlation of PET data with histopathological data (including the use of immunohistochemical markers) | Baseline | ||
Secondary | Evaluation of the sensitivity of PET in the detection of the involvement of hematopoietic marrow | Baseline | ||
Secondary | Comparison of conventional criteria for evaluating the response to the criteria "revised" by the international workshop criteria | 30 weeks |
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