UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective observational study for the risk of hepatitis B virus reactivation in patients with T-cell lymphoma who received mogamulizumab-containing chemotherapy
Acronym	Risk of hepatitis B virus reactivation after mogamulizumab-containing chemotherapy
Scientific Title	Retrospective observational study for the risk of hepatitis B virus reactivation in patients with T-cell lymphoma who received mogamulizumab-containing chemotherapy
Scientific Title:Acronym	PROACTIVE-MOGA study
Region	Japan

Condition
Condition	T-cell lymphoma patients with HBsAg-positive or resolved HBV infection
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine the risk of HBV reactivation in T-cell lymphoma patients with HBsAg-positive or resolved HBV infection who received mogamulizumab-containing chemotherapy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of HBV reactivation
Key secondary outcomes	Incidence of hepatitis and severity of hepatitis (requiring systemic steroids) Incidence of HBV reactivation-related hepatitis Incidence of HBV reactivation-related fulminant hepatitis Incidence of HBV reactivation-related mortality Incidence of decompensated liver cirrhosis (if patients with HBsAg-positive) Incidence of hepatocellular carcinoma (if patients with HBsAg-positive) Incidence of hepatocellular carcinoma-related mortality (if patients with HBsAg-positive) Incidence of anti-HBV prophylaxis using nucleoside/nucleotide analogues (if patients with HBsAg-positive) Incidence of anti-HBV treatment using nucleoside/nucleotide analogues (if patients with resolved HBV infection) Overall survival

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
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with T-cell lymphoma histologically diagnosed including adult T-cell leukemia-lymphoma or cutaneous T-cell lymphoma 2) Patients with seropositive for HBsAg or resolved HBV infection (defined as HBsAg-negative but seropositive for anti-HBc or anti-HBs). Patients with seronegative for HBsAg and anti-HBc but seropositive for anti-HBs were excluded if he/she had a history of HB vaccination. 3) Patients who received mogamulizumab-containing chemotherapy 4) Patients who underwent HBV DNA monitoring (defined as at least one measurement of HBV DNA level after starting of mogamulizumab) 5) Patients older than age 20 years
Key exclusion criteria	1) Patients with seropositive for anti-HCV. Patients without measurement for ant-HCV were eligible. 2) Patients with seropositive for anti-HIV. Patients without measurement for ant-HIV were eligible.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kisato Middle name Last name Nosaka
Organization	Kumamoto University Hospital
Division name	Cancer Center
Zip code	860-8556
Address	1-1-1 Honjo, Chuo-ku, Kumamoto
TEL	096-373-5156
Email	knosaka@kumamoto-u.ac.jp

Public contact
Name of contact person	1st name Kisato Middle name Last name Nosaka
Organization	Kumamoto University Hospital
Division name	Cancer Center
Zip code	860-8556
Address	1-1-1 Honjo, Chuo-ku, Kumamoto
TEL	096-373-5156
Homepage URL
Email	knosaka@kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
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	Faculty of Life Sciences, Kumamoto University
Address	1-1-1 Honjo, Chuo-ku, Kumamoto
Tel	096-344-2111
Email	ski-somu@kumamoto-u.ac.jp

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

尼崎総合医療センター（兵庫県） 安城更生病院（愛知県） いづろ今村病院（鹿児島県） 今村総合病院（鹿児島県） 大分大学医学部附属病院（大分県） 大阪国際がんセンター（大阪府） 大阪大学医学部附属病院（大阪府） 岡山大学病院（岡山県） 鹿児島大学病院（鹿児島県） がん研究会有明病院（東京都） 岐阜大学医学部附属病院（岐阜県） 九州大学病院（福岡県） 九州がんセンター（福岡県） 九州医療センター（福岡県） 京都第一赤十字病院（京都府） 京都大学医学部附属病院（京都府） 京都府立医科大学附属病院（京都府） 熊本医療センター（熊本県） くまもと森都総合病院（熊本県） 熊本総合病院（熊本県） 熊本大学病院（熊本県） 倉敷中央病院（岡山県） 県立宮崎病院（宮崎県） 高知大学医学部附属病院（高知県） 神戸大学医学部附属病院（兵庫県） 神戸中央病院（兵庫県） 国立がん研究センター中央病院（東京都） 国立がん研究センター東病院（千葉県） 埼玉医科大学国際医療センター（埼玉県） 佐世保市総合医療センター（長崎県） 産業医科大学病院（福岡県） JR大阪鉄道病院（大阪府） 四国がんセンター（愛媛県） 島根大学医学部附属病院（島根県） 順天堂大学医学部附属練馬病院（東京都） 昭和大学病院（東京都） 市立豊中病院（大阪府） 第二大阪警察病院（大阪府） 千葉大学医学部附属病院（千葉県） 天使病院（北海道） 東京大学医科学研究所附属病院（東京都） 東北大学病院（宮城県） 鳥取大学医学部附属病院（鳥取県） 中頭病院（沖縄県） 長崎医療センター（長崎県） 長崎大学病院（長崎県） 名古屋市立大学病院（愛知県） 広島赤十字・原爆病院（広島県） 兵庫県立がんセンター（兵庫県） 福岡大学病院（福岡県） 宮崎大学医学部附属病院（宮崎県） 和歌山県立医科大学附属病院（和歌山県）

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 17 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
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2022 Year 02 Month 01 Day
Date of IRB	2022 Year 05 Month 19 Day
Anticipated trial start date	2022 Year 06 Month 17 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Multicenter retrospective observational study

Management information
Registered date	2022 Year 06 Month 13 Day
Last modified on	2022 Year 06 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054749

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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