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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001299
Receipt No. R000001562
Scientific Title 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)
Date of disclosure of the study information 2008/08/11
Last modified on 2019/01/24

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Basic information
Public title 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)
Acronym HBV reactivation study during systemic chemotherapy containing rituximab plus steroid for malignant lymphoma (C-SHOT 0802)
Scientific Title 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)
Scientific Title:Acronym 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
1st name
Middle name
Last name Shigeru Kusumoto
Organization Nagoya City University Graduate School of
Medical Sciences
Division name Hematology and Oncology
Zip code
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
1st name
Middle name
Last name Shigeru Kusumoto
Organization Nagoya City University Graduate School of Medical Sciences
Division name Hematology and Oncology
Zip code
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)

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

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

Related information
URL releasing protocol http://www.c-shot.or.jp/study/0802/outline/
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25935551
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 Completed
Date of protocol fixation
2008 Year 06 Month 09 Day
Date of IRB
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

Other
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

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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