Positron Emission Tomography (PET)-Scan in the Evaluation of High Tumor Burden Follicular Lymphoma
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ClinicalTrials.gov Identifier: NCT00915096
Verified March 2010 by Lymphoma Study Association. Recruitment status was: Active, not recruiting
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.
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
High Tumor Burden Follicular Lymphoma patients
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.
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,