Untreated CD20-positive, B-cell non-Hodgkin'
Conditions
Interventions
None listed
Sponsors
Nagoya City University Hospital
NPO Center for Supporting Hematology-Oncology Trials (C-SHOT) SRL,Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed B-cell non-Hodgkin's lymphoma 2)CD20-positive 3)Seropositive for hepatitis B virus core antibody (HBc-Ab+) and/or hepatitis B surface antibody (HBs-Ab+) in patients with seronegativity for hepatitis B surface antigen(HBsAg-) 4)No prior systemic chemotherapy 5)Planned to be treated with 6-8 courses of systemic chemotherapy containing rituximab plus steroid such as R-CHOP, R-CVP,R-THP-COP and R-C-MOPP (Regardless of administration schedule of rituximab) 6)20<=age<=79 7)ECOG PS 0-2 8)Normal hepatic, renal, cardiac and pulmonary function 9)Written informed consent by the patient
Exclusion criteria
Exclusion criteria: 1)Isolated seropositivity for hepatitis B surface antibody (HBs-Ab+) in patients with a history of vaccination for hepatitis B virus 2)Seropositive to HCV 3)Seropositive to HIV 4)Liver cirrhosis 5)Serious infection 6)Planned to be treated with dialysis 7)Active coronary artery disease, cardiomyopathy, heart failure or arrhythmia 8)Have a history of glaucoma 9)Diabetes mellitus requiring insulin 10)Double cancer 11)Pregnant or lactating 12)Planned to be treated with hematopoietic stem-cell transplantation (autologous or allogeneic) on enrollment 13)Treated with major tranquilizer or antidepressant 14)Treated continuously with systemic steroids over 10mg per day (>10mg/day) 15)Plan to move house or to be transferred to another hospital within 1.5 years(have difficulty in serial HBV-DNA monitoring for 1.5 years) 16)Other conditions considered inappropriate by a physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hepatitis B virus (HBV) reactivation by means of serial HBV-DNA monitoring | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of hepatitis due to HBV reactivation Incidence of fulminant hepatitis due to HBV reactivation Mortality caused by hepatitis due to HBV reactivation Incidence of HBV reactivation following salvage chemotherapy Overall survival Incidence of serious adverse event Efficacy of preemptive therapy using anti-HBV nucleoside analogue | — |
Countries
Japan
Contacts
Public ContactShigeru Kusumoto
Nagoya City University Graduate School of Medical Sciences Hematology and Oncology
Outcome results
None listed