Status:
COMPLETED
Positron Emission Tomography (PET)-Scan in the Evaluation of High Tumor Burden Follicular Lymphoma
Lead Sponsor:
Lymphoma Study Association
Conditions:
Lymphoma, Follicular
Eligibility:
All Genders
18-80 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 18 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 8 2013
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00915096
Start Date
September 18 2007
End Date
February 8 2013
Last Update
August 23 2018
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU - Besançon
Besançon, France
2
CHU Avicenne
Bobigny, France
3
Centre Bergognié
Bordeaux, France
4
Hôpital Henri Mondor
Créteil, France