UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief title)	HBV reactivation study during systemic chemotherapy containing rituximab plus steroid for malignant lymphoma (C-SHOT 0802)
Region	Japan

Condition
Condition	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
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the incidence of hepatitis B virus reactivation by means of serial HBV-DNA monitoring during and just after systemic chemotherapy containing rituximab plus steroid for the lymphoma patients with seronegativity for HBsAg and seropositivity for HBc-Ab and/or HBs-Ab, and to collect and analyse the data for establishing preemptive therapy using anti-HBV nucleoside analogue
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of hepatitis B virus (HBV) reactivation by means of serial HBV-DNA monitoring
Key secondary outcomes	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

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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Histologically confirmed B-cell non-Hodgkin's lymphoma 2)CD20-positive 3)Seropositive for hepatitis B virus core antibody (HBc-Ab+) and/or hepatitis B surface antibody (HBs-Ab+) in patients with seronegativity for hepatitis B surface antigen(HBsAg-) 4)No prior systemic chemotherapy 5)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 (Regardless of administration schedule of rituximab) 6)20<=age<=79 7)ECOG PS 0-2 8)Normal hepatic, renal, cardiac and pulmonary function 9)Written informed consent by the patient
Key exclusion 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
Target sample size	321

Research contact person
Name of lead principal investigator	Shigeru Kusumoto
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Hematology and Oncology
Address	1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL	052-853-8738
Email	kusshan@rb3.so-net.ne.jp

Public contact
Name of contact person	Shigeru Kusumoto
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Hematology and Oncology
Address	1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL	052-853-8738
Homepage URL	http://www.c-shot.or.jp/study/0802/outline/
Email	kusshan@rb3.so-net.ne.jp

Sponsor
Institute	Nagoya City University Hospital
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	NPO Center for Supporting Hematology-Oncology Trials (C-SHOT) SRL,Inc.
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2008 Year 08 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 06 Month 09 Day
Anticipated trial start date	2008 Year 08 Month 01 Day
Last follow-up date	2014 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	http://www.c-shot.or.jp/study/0802/outline/
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/25935551
Results
Other related information	Prospective cohort study Correlative study by using preserved specimen 1)HBV-DNA measurement based on real-time PCR assay with ultra-high sensitivity 2)Serum marker measurement of HBV:HBsAg, HBV core-related antigen, HBc-Ab, HBs-Ab 3)Sequence analysis of HBV genes in cases with reactivation in a cohort 4)Mutation analysis of HBV genes in cases with reactivation in a cohort

Management information
Registered date	2008 Year 08 Month 05 Day
Last modified on	2019 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001562