low and low-intermediate risk of aggressive non-Hodgkin's lymphoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) histologically diagnosed non-Hodgkin's lymphoma with intermediate or high grade by Working Formulation, except for transformation from low grade lymphoma, ATL, T-lymphoblastic lymphoma, mycosis fungoideus, and Sezary syndrome. (2) Clinical stage of I-bulky, II, III, IV by Ann Arbor classification. (3) No previous chemotherapy or radiotherapy. (4) Age: between 15 and 69. (5) Performance Status: between 0 and 3. (6) Low or low-intermediate risk by International index (7) No organ dysfuction; neutrophil count>1200/ml, platelet count >75000/ml, ASTand ALT level <5 times the upper limit of the normal range, total bilirubin level < 2.0 mg/dl, serum creatinin level < 2.0mg/dl, no cardiac dysfunction. (8) Understanding and agreement of written informed consent.
Exclusion criteria
Exclusion criteria: 1) Complication; severe infection, heart failure, respiratory failure, hepatic failure, organic pulumonary disease, liver cirrhosis, acute or chronic hepatitis, renal failure. 2) Active or non-curable synchronous malignancy, except for cervical carcinoma in situ or basal carcinoma of the skin. 3) Psycological disorder like schizophrenia. 4) Heart disease which is deteriorated by anthracyclins, past history of myocardial infarction, or angina pectoris during 3 months before registration. 5) Pregnant or nursing . 6) Involvement of central nervous system 7) HIV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission rate, Progression free survaval, adverse reaction/adverse effect | — |
Countries
Japan
Contacts
JCOG9508 Coordinating Office Department of Hematology and Cell-therapy, Aichi Cancer Center Hospital