{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"52"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"}],"units":"Participants"}],"description":"Complete Response Rate (CR) was reported at the end of the CEOP-P (6 courses for patients not receiving transplant and 4-6 courses for patients receiving transplant). Response assessment was performed by computerized tomography (CT) or positron emission tomography (PET)/CT based on the investigator's preference after cycles 2, 4 and 6. Response was assessed by the treating physician according to the Cheson Revised response criteria (Cheson et al,, 2007) or International Harmonization Project criteria (Cheson, 2007), based on imaging modality used.\n\nComplete Response Definition: Disappearance of all evidence of disease Nodal Masses: (a) \\[18F\\]fluorodeoxyglucose(FDG)-avid or PET positive prior to therapy; mass of any size permitted if PETnegative (b) Variably FDG-avid or PET negative; regression to normal size on CT Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative","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":"168 days - 252 days (4-6 courses; 42 days per course)","title":"Complete Response Rate of Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) and Pralatrexate (P) Treatment","type":"PRIMARY","unitOfMeasure":"percentage of participants analyzed"}