A multicenter, observational study for reactivation of hepatitis B virus by means of serial HBV-DNA monitoring during and just after systemic chemotherapy containing rituximab plus steroid for malignant lymphoma (C-SHOT 0802)

UMIN ID: UMIN000001299

Registered date:11/08/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Untreated CD20-positive, B-cell non-Hodgkin's lymphoma in the patients with seronegativity for HBsAg and seropositivity for HBc-Ab and/or HBs-Ab, which is 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
• Date of first enrollment: 2008/08/01
• Target sample size: 321
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Incidence of hepatitis B virus (HBV) reactivation by means of serial HBV-DNA monitoring
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Nagoya City University Hospital
• Secondary Sponsor: NPO Center for Supporting Hematology-Oncology Trials (C-SHOT) SRL,Inc.
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare