Unique ID issued by UMIN | UMIN000025574 |
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Receipt number | R000029423 |
Scientific Title | Multicenter retrospective observational study for hepatitis B virus reactivation-related liver complications in HBsAg-positive patients with diffuse large B-cell lymphoma following rituximab-containing chemotherapy |
Date of disclosure of the study information | 2017/01/09 |
Last modified on | 2022/08/22 09:39:57 |
Multicenter retrospective observational study for hepatitis B virus reactivation-related liver complications in HBsAg-positive patients with diffuse large B-cell lymphoma following rituximab-containing chemotherapy
Retrospective study for hepatitis B virus reactivation in HBsAg-positive lymphoma patients
Multicenter retrospective observational study for hepatitis B virus reactivation-related liver complications in HBsAg-positive patients with diffuse large B-cell lymphoma following rituximab-containing chemotherapy
Retrospective study for hepatitis B virus reactivation in HBsAg-positive lymphoma patients
Japan |
Diffuse large B-cell lymphoma
Hematology and clinical oncology |
Malignancy
NO
Main purpose of this retrospective study is to clarify the characteristics and incidence of hepatitis B virus (HBV) reactivation-related complications in HBsAg-positive patients with diffuse large B-cell lymphoma following rituximab-containing chemotherapy.
Safety,Efficacy
Exploratory
Explanatory
Not applicable
Incidence and severity of liver damage both in HBsAg-positive and -negative group
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
Observational
20 | years-old | <= |
Not applicable |
Male and Female
[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 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
500
1st name | |
Middle name | |
Last name | Shigeru Kusumoto |
Nagoya City University Graduate School of Medical Sciences
Department of Hematology and Oncology
1 Kawasumi, Mizuho chou, Mizuho ku, Nagoya, Aichi 4678601, Japan
052-853-8738
skusumot@med.nagoya-cu.ac.jp
1st name | |
Middle name | |
Last name | Nobuhiko Yamauchi/Dai Maruyama |
National Cancer Center Hospital
Department of Hematology
5 1 1 Tsukiji, Chuo ku, Tokyo, 1040045, Japan.
03-3542-2511
dmaruyam@ncc.go.jp
Department of Hematology, National Cancer Center Hospital
Research Program on Hepatitis from Japan Agency for Medical Research and Development (AMED)
Japanese Governmental office
Japan
NO
国立病院機構北海道がんセンター(北海道)
東北大学病院(宮城県)
群馬大学医学部附属病院(群馬県)
群馬県立がんセンター(群馬県)
千葉県がんセンター(千葉県)
国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
虎の門病院(東京都)
神奈川県立がんセンター(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
埼玉県立がんセンター(埼玉県)
横浜市立大学附属病院(神奈川県)
信州大学医学部附属病院(長野県)
東海中央病院(愛知県)
名古屋第二赤十字病院(愛知県)
愛知県がんセンター中央病院(愛知県)
名古屋市立大学病院(愛知県)
豊田厚生病院(愛知県)
国立病院機構名古屋医療センター(愛知県)
名古屋大学医学部附属病院(愛知県)
愛知医科大学附属病院(愛知県)
藤田保健衛生大学医学部(愛知県)
安城更生病院(愛知県)
滋賀県立成人病センター(滋賀県)
京都府立医科大学附属病院(京都府)
兵庫県立がんセンター(兵庫県)
岡山労災病院(岡山県)
島根大学病院(島根県)
国立病院機構九州がんセンター(福岡県)
大分県立病院(大分県)
佐賀大学病院(佐賀県)
熊本大学医学部附属病院(熊本県)
国立病院機構熊本医療センター(熊本県)
佐世保市総合医療センター(長崎県)
長崎大学病院(長崎県)
国立病院機構長崎医療センター(長崎県)
鹿児島大学病院(鹿児島県)
2017 | Year | 01 | Month | 09 | Day |
Unpublished
Main results already published
2016 | Year | 12 | Month | 11 | Day |
2016 | Year | 12 | Month | 22 | Day |
2017 | Year | 01 | Month | 04 | Day |
2017 | Year | 12 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
Multicenter retrospective observational study:
We evaluate the HBV reactivation-related complications of HBsAg-positive group compared to those of HBsAg-negative group as a control.
We also clarify the clinical significance of antiviral prophylaxis using anti-HBV nucleos(t)ide analogue and the optimal period of antiviral prophylaxis for HBsAg-positive patients.
2017 | Year | 01 | Month | 07 | Day |
2022 | Year | 08 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029423
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