Lymphoma, Follicular
Conditions
Keywords
Follicular Lymphoma, PET, GELA
Brief summary
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.
Interventions
None listed
Sponsors
Lymphoma Study Association
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Predictive value of PET on progression-free survival | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of PET data with FLIPI index score | Baseline |
| Comparison of changes in lymph node volumes measured by CT to changing of FDG fixation | 30 weeks |
| Comparison of PET results to treatment response (Cheson criteria) | 30 weeks |
| Evaluation of the sensitivity of PET in the detection of the involvement of hematopoietic marrow | Baseline |
| Comparison of conventional criteria for evaluating the response to the criteria revised by the international workshop criteria | 30 weeks |
| Correlation of PET data with histopathological data (including the use of immunohistochemical markers) | Baseline |
Countries
France, Italy
Outcome results
None listed