This trial is active, not recruiting.

Condition lymphoma, follicular
Sponsor Lymphoma Study Association
Start date September 2007
End date September 2011
Trial size 120 participants
Trial identifier NCT00915096, PET-FOL, PRC06002


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Predictive value of PET on progression-free survival
time frame: 2 years

Secondary Outcomes

Comparison of PET results to treatment response (Cheson criteria)
time frame: 30 weeks
Correlation of PET data with FLIPI index score
time frame: Baseline
Comparison of changes in lymph node volumes measured by CT to changing of FDG fixation
time frame: 30 weeks
Correlation of PET data with histopathological data (including the use of immunohistochemical markers)
time frame: Baseline
Evaluation of the sensitivity of PET in the detection of the involvement of hematopoietic marrow
time frame: Baseline
Comparison of conventional criteria for evaluating the response to the criteria "revised" by the international workshop criteria
time frame: 30 weeks

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title High Tumor Burden Follicular Lymphoma: Impact of [18F]-FDG Positron Emission Tomography (PET) in the Assessment of Treatment Response
Principal investigator Michel MEIGNAN, Prof
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by Lymphoma Study Association.