{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"70"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"}],"units":"Participants"}],"description":"Every patient who fulfills all aspects of patient eligibility who receives at least 2 complete courses of chemotherapy will be evaluable for the response endpoint. Response rates will be descriptively summarized using percentages and 95% confidence intervals.\n\nComplete Response Definition: Defined in Primary Objective Partial Response Definition: Regression of measurable disease and no new sites, Nodal Masses: \\> 50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes\n\n1. FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site\n2. Variably FDG-avid or PET negative; regression on CT Spleen, Liver:\\> 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified","groups":[{"description":"Patients receive cyclophosphamide IV and vincristine sulfate IV on day 1, etoposide IV on days 1-3 or PO QD on days 2-3, and prednisone PO QD on days 1-5 (CEOP administration). Patients also receive pralatrexate IV over 3-5 minutes on days 15, 22, and 29 (P administration). Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients with CR or PR, per investigators discretion, may then undergo hematopoietic stem cell collection and administration of standard preparative regimen followed by hematopoietic stem cell transplantation.\n\nprednisone: Given PO\n\ncyclophosphamide: Given IV\n\netoposide: Given PO or IV\n\nvincristine sulfate: Given IV\n\npralatrexate: Given IV\n\nlaboratory biomarker analysis: Correlative studies\n\ncomparative genomic hybridization: Correlative studies\n\ngene expression analysis: Correlative studies\n\nnucleic acid sequencing: Correlative studies\n\nmutation analysis: Correlative studies","id":"OG000","title":"Treatment (Chemotherapy and Enzyme Inhibitor Therapy)"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"2 years","title":"Overall Response Rates (ORR)= (Complete Response Rates (CR) + Partial Response Rates (PR))","type":"SECONDARY","unitOfMeasure":"percentage of participants analyzed"}