Prognostic Significance of Early Positron Emission Tomography (PET) With Fluorine-18 Fluorodeoxyglucose ([18F] FDG) in Intermediate and High Grade Non-Hodgkin's Lymphoma
- Determine the positive and negative predictive values of early positron emission
tomography (PET) scanning using fludeoxyglucose F 18 in terms of the probability of
patients with newly diagnosed intermediate- or high-grade non-Hodgkin's lymphoma who
achieve or do not achieve complete remission, after treatment with 1 course of
rituximab and combination chemotherapy comprising cyclophosphamide, doxorubicin,
vincristine, and prednisone.
- Determine event free and overall survival of patients with an early positive and
negative PET scan treated with this regimen.
- Determine the predictive value of early PET scan response ratio as a continuous
variable in terms of response to therapy (assessed at the end of therapy), disease-free
survival, and overall survival, in patients treated with this regimen.
- Correlate International Prognostic Index score at presentation with early PET scan
results and overall outcome in patients treated with this regimen.
- Correlate the degree of neutropenia 7 to 10 days after the first course of treatment
with rituximab and combination chemotherapy with PET scan response and pre-treatment
blood CD34-positive cell concentration in these patients.
OUTLINE: This is a multicenter study.
Patients receive fludeoxyglucose F 18 (^18FDG) IV. Beginning 1 hour later, patients undergo
whole-body positron emission tomography (PET) scanning. Patients also undergo conventional
radiographic staging of their disease.
Patients then receive standard R-CHOP (or an alternative regimen) comprising rituximab IV
over 3-6 hours, cyclophosphamide IV over 30 minutes, doxorubicin IV over 5 minutes, and
vincristine IV over 5 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment
repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.
Patients undergo repeat ^18FDG-PET scanning between days 7-10 of course 1, between courses 3
and 4, and then at the completion of R-CHOP. Patients also undergo radiographic restaging of
their disease between courses 3 and 4 and at the completion of R-CHOP.
After completion of study treatment, patients are followed every 3-4 months for 2 years,
every 6 months for 1 year, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Complete remission as measured by positron emission tomography (PET) at 7-10 days after R-CHOP, and after completion of study treatment
at 7-10 days after R-CHOP, and after completion of study treatment
Panayiotis Savvides, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government