Conditions: Lymphoma
Keywords: contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 80
Healthy volunteers: no

Brief summary:
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with diffuse large B-cell lymphoma.

Detailed description:
OBJECTIVES:

Primary

* Determine the clinical response rate in older patients with previously untreated aggressive diffuse large B-cell stage II-IV lymphoma treated with rituximab, cyclophosphamide, pegylated doxorubicin hydrochloride liposome (HCl), vincristine, and prednisone.
* Determine the cardiotoxicity and myelosuppression of this regimen in these patients.

Secondary

* Determine disease-free survival and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive rituximab intravenous (IV), cyclophosphamide IV over 1-1½ hours, pegylated doxorubicin HCl liposome IV over 1 hour, and vincristine IV on day 1, and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on day 6 (24 hours after the completion of chemotherapy). Treatment repeats every 21 days for up to 8 courses in the absence of unacceptable toxicity, disease progression, active hepatitis B virus infection, or hepatitis. Patients with no response OR who achieve less than a partial response after 4 courses are removed from the study.

Patients are followed at 1 month, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A maximum of 80 patients will be accrued for this study within 27 months.

Arms:
arm 1: Rituximab 375 mg/m\^2 intravenous (IV), Cyclophosphamide IV over 1-1½ hours, Pegylated doxorubicin HCl liposome 40 mg/m\^2 IV over 1 hour, Vincristine 2 mg IV, day 1, \& oral Prednisone 40 mg/m\^2 days 1 - 5; Filgrastim (G-CSF) 5 mcg/kg subcutaneously (SC) once daily beginning day 6 continuing until blood counts recover OR Pegfilgrastim 6 mg SC once on day 6 (24 hours after chemotherapy). Treatment repeats every 21 days for up to 8 courses.

Interventions: intervention 1: Filgrastim intervention 2: Pegfilgrastim intervention 3: Rituximab intervention 4: Cyclophosphamide intervention 5: Pegylated liposomal doxorubicin hydrochloride intervention 6: Prednisone intervention 7: Vincristine Sulfate
Intervention descriptions: intervention 1: 5 mcg/kg, SC daily, start 24 hours after chemotherapy intervention 2: 6 mg SC one time (24 hours after chemotherapy) intervention 3: 375 mg/m\^2 intravenous piggy back (IVPB) on day 1, administered 1st intervention 4: 750 mg/m\^2 IVPB on day 1 intervention 5: 40 mg/m\^2 IV (maximum dose 90 mg) infusion over 1 hour on day 1 intervention 6: 40 mg/m\^2 oral days 1 - 5. intervention 7: 2 mg IV, day 1

Protocol document: