PET Scans in Patients With Diffuse Large B-Cell Lymphoma Receiving Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional

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.
    

Intervention name(s): rituximab; cyclophosphamide; doxorubicin hydrochloride; prednisone; vincristine sulfate; positron emission tomography
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Procedure
Intervention description(s): 375 mg/m2 i.v. per cycle; 750 mg/m2 i.v. per cycle; 50 mg/m2 i.v. per cycle; 100 mg/day p.o. per cycle; 1.4 mg/m2 (max. 2.0 mg) i.v. per cycle; PET Scan during treatment
Other intervention name(s): Mabthera; Endoxan; Adriamycin, Adriblastin; Deltasone, Orasone; Oncovin
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Vincristine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; stage I adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma