Diffuse large B-cell lymphoma
Conditions
Interventions
None listed
Sponsors
Department of Hematology, National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [Eligibility criteria for HBsAg-positive group] HBsAg-positive group is defined as untreated diffuse large B-cell lymphoma (DLBCL) who were histopathologically diagnosed between January 2004 and December 2014 at each institution. Inclusion criteria: 1) Histopathologically diagnosed as having DLBCL including histological transformation from indolent lymphoma 2) Confirmed to be seropositive for HBsAg at baseline 3) Confirmed to be CD20-positive lymphoma by immunohistochemistry or flowcytometry 4) Patients who received R-CHOP or R-THP-COP regimen for DLBCL as an initial chemotherapy regardless of steroid use 5) 20 years or older at diagnosis of DLBCL [Eligibility criteria for HBsAg-negative group] HBsAg-negative group is defined as untreated diffuse large B-cell lymphoma (DLBCL) who were histopathologically diagnosed between January 2004 and December 2014 at each institution. Inclusion criteria: 1) Confirmed to be seronegative for HBsAg at baseline regardless of anti-HBc or anti-HBs 2) Histopathologically diagnosed as having DLBCL during the same period of HBsAg-positive group (diagnosed within a month of each patient in HBsAg-positive group) 3) Confirmed to be CD20-positive lymphoma by immunohistochemistry or flowcytometry 4) Patients who received R-CHOP or R-THP-COP regimen for DLBCL as an initial chemotherapy regardless of steroid use 5) 20 years or older at diagnosis of DLBCL
Exclusion criteria
Exclusion criteria: Exclusion criteria for HBsAg-positive group: 1) Seropositive for hepatitis C virus 2) Seropositive for human immunodeficiency virus 3) Alanine transaminase level of 100 U/L or more at baseline 4) Lymphoma involvement of central nervous system at diagnosis of DLBCL regardless of primary or secondary one 5) Diagnosed as having intravascular lymphoma or primary testicular lymphoma 6) Have a history of systemic chemotherapy for hematological malignancies or solid tumors 7) Diagnosed as having decompensated cirrhosis or hepatocellular carcinoma at diagnosis of DLBCL or have a history of decompensated cirrhosis or hepatocellular carcinoma Exclusion criteria for HBsAg-negative group: 1) Seropositive for HBsAg before or at diagnosis of DLBCL 2) Seropositive for hepatitis C virus 3) Seropositive for human immunodeficiency virus 4) Alanine transaminase level of 100 U/L or more at baseline 5) Lymphoma involvement of central nervous system at diagnosis of DLBCL regardless of primary or secondary one 6) Diagnosed as having intravascular lymphoma or primary testicular lymphoma 7) Have a history of systemic chemotherapy for hematological malignancies or solid tumors 8) Diagnosed as having decompensated cirrhosis or hepatocellular carcinoma at diagnosis of DLBCL or have a history of decompensated cirrhosis or hepatocellular carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of liver damage both in HBsAg-positive and -negative group | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Incidence of HBV reactivation-related liver damage both in HBsAg-positive and -negative group 2) Incidence of HBV reactivation-related acute liver failure (fulminant hepatitis) both in HBsAg-positive and -negative group 3) Incidence of decompensated liver cirrhosis both in HBsAg-positive and -negative group 4) Incidence of hepatocellular carcinoma both in HBsAg-positive and -negative group 5) Incidence of HBV reactivation-related liver damage after cessation of antiviral prophylaxis using anti-HBV nucleos(t)ide analogue in HBsAg-positive group. 6) Overall response rate and complete response rate of first-line rituximab-containing chemotherapy for diffuse large B-cell lymphoma both in HBsAg-positive and -negative group 7) Mortality rate of HBV reactivation-related liver damage both in HBsAg-positive and -negative group 8) Mortality rate of hepatocellular carcinoma both in HBsAg-positive and -negative group 9) Progression free survival of diffuse large B-cell lymphoma both in HBsAg-positive and -negative group 10) Overall survival of diffuse large B-cell lymphoma both in HBsAg-positive and -negative group | — |
Countries
Japan
Contacts
Public ContactNobuhiko Yamauchi/Dai Maruyama
National Cancer Center Hospital Department of Hematology
Outcome results
None listed