NCT00544219

PET Scans in Patients With Diffuse Large B-Cell Lymphoma Receiving Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	rituximab	375 mg/m2 i.v. per cycle
DRUG	cyclophosphamide	750 mg/m2 i.v. per cycle
DRUG	doxorubicin hydrochloride	50 mg/m2 i.v. per cycle
DRUG	prednisone	100 mg/day p.o. per cycle
DRUG	vincristine sulfate	1.4 mg/m2 (max. 2.0 mg) i.v. per cycle
PROCEDURE	positron emission tomography	PET Scan during treatment

Timeline

• Start date: 2007-09-01
• Primary completion: 2012-09-01
• Completion: 2016-01-01
• First posted: 2007-10-16
• Last updated: 2019-05-15

Locations

19 sites across 2 countries: Italy, Switzerland