Prospective Evaluation of the Predictive Value of PET in Patients With Diffuse Large B-cell-lymphoma Under R-CHOP-14. A Multicenter Study

Brief Summary

Detailed Description

OBJECTIVES: Primary * 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. Secondary * To compare modified PET/CT scan response criteria with revised standard response criteria. * 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) expression. After completion of study treatment, patients are followed periodically for up to 5 years.

Primary Outcomes

Secondary Outcomes

• Event-free survival(at 5 years)
• Overall survival during follow-up(at 2 and 5 years)
• Objective response(at 2 years)
• Positron emission tomography (PET) results(at 2 years)
• Histological results of remaining PET-positive lesion(s) after treatment(at 2 years)