RATIONALE: Studying PET scans given to patients with cancer who are undergoing treatment may help doctors predict how patients will respond to treatment. PURPOSE: This clinical trial is studying PET scans in patients with diffuse large B-cell lymphoma who are receiving rituximab together with cyclophosphamide, doxorubicin, vincristine, and prednisone.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
156
375 mg/m2 i.v. per cycle
750 mg/m2 i.v. per cycle
50 mg/m2 i.v. per cycle
European Institute of Oncology
Milan, Italy
Hirslanden Klinik Aarau
Aarau, Switzerland
Event-free survival
Time frame: at 2 years
Event-free survival
Time frame: at 5 years
Overall survival during follow-up
Time frame: at 2 and 5 years
Objective response
Time frame: at 2 years
Positron emission tomography (PET) results
Time frame: at 2 years
Histological results of remaining PET-positive lesion(s) after treatment
Time frame: at 2 years
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100 mg/day p.o. per cycle
1.4 mg/m2 (max. 2.0 mg) i.v. per cycle
PET Scan during treatment
Kantonspital Aarau
Aarau, Switzerland
Kantonsspital Baden
Baden, Switzerland
Praxis Dr. Streit
Baden, Switzerland
Saint Claraspital AG
Basel, Switzerland
Universitaetsspital-Basel
Basel, Switzerland
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland
Inselspital Bern
Bern, Switzerland
Kantonsspital Bruderholz
Bruderholz, Switzerland
...and 9 more locations