Prospective Evaluation of the Predictive Value of PET in Patients With Diffuse Large B-cell-lymphoma Under R-CHOP-14. A Multicenter Study
- To evaluate if an early positive positron emission tomography (PET) scan after 2
courses of rituximab with cyclophosphamide, doxorubicin hydrochloride, vincristine, and
prednisone can be used to identify a group of patients having a poor prognosis.
- To compare modified PET/CT scan response criteria with revised standard response
- To evaluate, in a prospective manner, whether a proliferation-inducing ligand (APRIL)
expression is a prognostic factor in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and
vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 14 days for
up to 6 courses in the absence of disease progression or unacceptable toxicity. Rituximab IV
alone is continued for an additional 2 courses after completion of the initial 6 courses.
Patients undergo positron emission tomography (PET) scan prior to and after completion of
study therapy. Patients also undergo PET scan after course 2, and those with a positive PET
result undergo an additional PET scan after course 4.
Previously collected tumor samples are analyzed for a proliferation-inducing ligand (APRIL)
After completion of study treatment, patients are followed periodically for up to 5 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
at 2 years
Christoph Mamot, MD