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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046603
Receipt No. R000053163
Scientific Title Humoral and T-cell responses to a third dose of BNT162b2 and mRNA-1273 COVID-19 Vaccine in Patients with hematological diseases treated with rituximab or obinutuzumab: An observational study.
Date of disclosure of the study information 2022/01/11
Last modified on 2022/01/11

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Basic information
Public title Humoral and T-cell responses to a third dose of BNT162b2 and mRNA-1273 COVID-19 Vaccine in Patients with hematological diseases treated with rituximab or obinutuzumab: An observational study.
Acronym Rituximab or obinutuzumab a third dose study
Scientific Title Humoral and T-cell responses to a third dose of BNT162b2 and mRNA-1273 COVID-19 Vaccine in Patients with hematological diseases treated with rituximab or obinutuzumab: An observational study.
Scientific Title:Acronym Rituximab or obinutuzumab a third dose study
Region
Japan

Condition
Condition Hematological diseases
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the efficacy and safety of a third dose of mRNA vaccine against SARS-CoV-2 in patients with hematologic diseases who have previously received rituximab or obinutuzumab.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint was the rate of positive SARS-CoV-2 IgG antibodies before and after the third vaccination.
Key secondary outcomes

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Adult patients who have received rituximab/obinutuzumab for hematological diseases (B-cell non-Hodgkin's lymphoma, B-cell lymphoproliferative disease under immunosuppressive conditions, chronic idiopathic thrombocytopenic purpura, acquired thrombocytopenic purpura)
2) Patients who have received the first and second doses of SARS-CoV-2 vaccination sponsored by the Japanese government or local government, the date and time of the vaccination can be confirmed, and the first dose of SARS-CoV-2 vaccine was administered within 12 months of the last dose of rituximab or obinutuzumab. The date and time of vaccination can be confirmed, and the first dose of SARS-CoV-2 vaccine is within 12 months of the last dose of rituximab/obinutuzumab.
3) Be willing to receive the third dose of SARS-CoV-2 vaccination initiated by the Japanese government or local government.
4) Written consent has been obtained from the subject for participation in the study.
Key exclusion criteria 1) Patients who are judged inappropriate for participation in the study by the investigators
2) Patients who have previously received rituximab for non-hematological diseases (polyangiitis granulomatosa, microscopic polyangiitis, refractory nephrotic syndrome)
3) Patients with a history of COVID-19
4) Patients with autoimmune diseases other than chronic idiopathic thrombocytopenic purpura (systemic lupus erythematosus, Sjogren's syndrome, dermatomyositis/polymyositis, mixed connective tissue disease, systemic scleroderma, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, spondyloarthritis and related diseases, vasculitis syndromes, inflammatory bowel disease, Guillain-Barre syndrome, and inflammatory bowel disease) Guillain-Barre syndrome, multiple sclerosis, neuromyelitis optica).
5) Patients who are unable to communicate with others
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takayuki
Middle name
Last name Ishikawa
Organization Kobe City Medical Center General Hospital
Division name Department of Hematology
Zip code 650-0047
Address 2-1-1 Minatojima-minami-machi Chuo-ku Kobe City Hyogo Japan
TEL 0783024321
Email ishikawa@kcho.jp

Public contact
Name of contact person
1st name Masashi
Middle name
Last name Nishikubo
Organization Kobe City Medical Center General Hospital
Division name Department of Hematology
Zip code 650-0047
Address 2-1-1 Minatojima-minami-machi Chuo-ku Kobe City Hyogo Japan
TEL 0783024321
Homepage URL
Email masashi_nishikubo@kcho.jp

Sponsor
Institute Kobe City Medical Center General Hospital, Department of Hematology
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kobe City Medical Center General Hospital
Address 2-1-1 Minatojima-minami-machi Chuo-ku Kobe City Hyogo Japan
Tel 0783024321
Email rinken@kcho.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

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 11 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 Preinitiation
Date of protocol fixation
2022 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2022 Year 01 Month 20 Day
Last follow-up date
2023 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing particular

Management information
Registered date
2022 Year 01 Month 11 Day
Last modified on
2022 Year 01 Month 11 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053163

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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