UMIN-CTR Clinical Trial

Basic information
Public 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
Acronym	Retrospective study for hepatitis B virus reactivation in HBsAg-positive lymphoma patients
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
Scientific Title:Acronym	Retrospective study for hepatitis B virus reactivation in HBsAg-positive lymphoma patients
Region	Japan

Condition
Condition	Diffuse large B-cell lymphoma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence and severity of liver damage both in HBsAg-positive and -negative group
Key secondary outcomes	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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shigeru Kusumoto
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Hematology and Oncology
Zip code
Address	1 Kawasumi, Mizuho chou, Mizuho ku, Nagoya, Aichi 4678601, Japan
TEL	052-853-8738
Email	skusumot@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Nobuhiko Yamauchi/Dai Maruyama
Organization	National Cancer Center Hospital
Division name	Department of Hematology
Zip code
Address	5 1 1 Tsukiji, Chuo ku, Tokyo, 1040045, Japan.
TEL	03-3542-2511
Homepage URL
Email	dmaruyam@ncc.go.jp

Sponsor
Institute	Department of Hematology, National Cancer Center Hospital
Institute
Department

Funding Source
Organization	Research Program on Hepatitis from Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

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）

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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Date of the first journal publication of results
Baseline Characteristics
Participant flow
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IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 12 Month 11 Day
Date of IRB	2016 Year 12 Month 22 Day
Anticipated trial start date	2017 Year 01 Month 04 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information	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.

Management information
Registered date	2017 Year 01 Month 07 Day
Last modified on	2022 Year 08 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029423