B-cell-Non-Hodgkin'
Conditions
Interventions
Rituximab containing-regimen and autologous stem cell transplantation for the responded patients as CR, CRu, PR after rituximab containing-induction chemotherapy
Sponsors
Kanazawa university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a)Age:20-69 b)PS(ECOG):0-2 c)High intermediate risk group(H-I) or high risk group(H) in untreated aggressive B-cell-NHL Relapsed or resistant for chemotherapy, radiotherapy, monoclonal antibody d)Pts who were previously treated with less than 2 regimens or prior radiotherapy at least 12 weeks before registration e)Life expectancy at least 12 weeks f)Pts must have normal marrow and organ function as defined below 1)Bone marrow function WBC>=3000/mm3 or neutrophil count>=1000/mm3 Platelet count>=100,000/mm3 Hemoglobin>=8.0g/dl 2)Liver function AST, ALT<=2.5xULN Total bilirubin<=1.5xULN 3)Renal fuction Serum creatinine <=1.5mg/dl 4)Cardiac function Normal electrocardiogram and cardiac function(without severe heart failure or cardiac arrhythmia) g)Pts who give a writen informed consent
Exclusion criteria
Exclusion criteria: a)Pts received allogeneic hematopoietic(hemopoietic) stem cell transplant or autologous stem cell transplantation greater than two times. b)Pts received rituximab at least 8 weeks before registration. c)Pts received chemotherapy or radiotherapy at least 4 weeks before registration(include induction chemotherapy supported with autologous stem cell transplantation). d)Allergy for monoclonal antibody. e)Pts who observed transformation at relapse. f)Other malignant diseases including simultaneous cancer and disease free state within 5 years after treatment. g)Presense of central nervous invasion(clinical). h)Severe heart failure(New York Heart Association: classIII, IV). i)Severe lung disease. j)Severe infectious disease. k)Positive test for HBs antigen, HCV antibody, HIV antigen, HIV antibody, HBc antibody, HBV-DNA. l)Past history of glaucoma. m)In-treatment diabetes mellitus with insulin. n)Pts who underwent surgery that requires general anesthesia at least 4 weeks before registration. o)Tumor cell>=25,000/mm3. p)Pts are pregnant or lactating women. q)Uncontrol of contraception at during the administration or at least 48 weeks after final dose. r)Psychological disease or psychological symptom that seems to be difficult to partcipate in clinical trial. s)Inadequate for clinical trial entry by the attending physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CMV infection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety | — |
Countries
Japan
Contacts
Public ContactAiko Sawazaki
Ishikawa prefectural central hospital Department of Hematology
Outcome results
None listed