Cyclophosphamide W/or W/Out Rituximab and Peripheral Stem Cell Transplantation in Patients With Recurrent Non-Hodgkin's Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL) Indolent or aggressive histology No small lymphocytic lymphoma, Burkitt's lymphoma, or small lymphocytic non-Burkitt's lymphoma CD20-positive and/or CD19-positive by immunohistochemistry or flow cytometry Second or greater remission allowed Partial remission, relapse, or refractory disease must have measurable tumor Eligible for high-dose therapy followed by autologous peripheral blood stem cell transplantation No CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age: 12 to 65 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,200/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine clearance at least 60 mL/min No renal dysfunction Cardiovascular: LVEF at least 40% No cardiac dysfunction No myocardial infarction within the past 3 months Pulmonary: FEV_1 greater than 60% DLCO at least 60% of predicted No pulmonary dysfunction No asthma Other: HIV negative No significant organ dysfunction No severe comorbid condition No uncontrolled diabetes No severe or active infection Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Chemotherapy No prior immunotherapy Chemotherapy: No prior high-dose chemotherapy with or without peripheral blood stem cell transplantation No more than 3 prior chemotherapy regimens for NHL At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Not specified
Sites / Locations
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I: with rituximab IV
Arm II: without rituximab IV