UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and Safety of the BNT162b2, mRNA-1273, and ChAdOx1-S COVID-19 Vaccine in Patients with hematological diseases treated with rituximab or obinutuzumab: An observational study.
Acronym	Anti-CD20-Ab mRNA COVID19 vaccine study
Scientific Title	Efficacy and Safety of the BNT162b2, mRNA-1273, and ChAdOx1-S COVID-19 Vaccine in Patients with hematological diseases treated with rituximab or obinutuzumab: An observational study.
Scientific Title:Acronym	Anti-CD20-Ab mRNA COVID19 vaccine study
Region	Japan

Condition
Condition	B cell non-Hodgkin lymphoma, Post-transplant Lymphoproliferative Disorders, Idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
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 positivity of SARS-CoV-2 IgG antibody titer after completion of BNT162b2, mRNA-1273, and ChAdOx1-S vaccination in patients with hematological diseases who have received rituximab and obinutuzumab, and to evaluate the post-vaccination adverse reactions that occurred when these vaccines were administered. The purpose of this study was to evaluate the positive rate of SARS-CoV-2 IgG antibody titer after completion of ChOx1-S vaccination, and to evaluate the post-vaccination adverse reactions that occurred when these vaccines were given.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint will be the rate of SARS-CoV-2 IgG antibody positivity.
Key secondary outcomes	Secondary endpoints will be SARS-CoV-2 IgG antibody titer, peripheral blood lymphocyte fraction, IgG, IgA, IgM, and presence and content of post-vaccination adverse reactions.

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 are willing to receive SARS-CoV-2 vaccination initiated by the Japanese government or local government. 3) Patients who have given written consent to participate in the study.
Key exclusion criteria	1) Patients whom the principal investigator or sub-investigator judges to be inappropriate for participation in the study 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 a history of or coexistence 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 syndrome, inflammatory bowel disease, Guillain-Barre syndrome, multiple sclerosis, neuromyelitis optica) 5) Patients who are unable to communicate with others
Target sample size	150

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	078-302-4321
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	078-302-4321
Homepage URL
Email	masashi_nishikubo@kcho.jp

Sponsor
Institute	Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization	Kobe City Medical Center General Hospital, Department of Hematology
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	078-302-5176
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	2021 Year 11 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	152
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	2021 Year 05 Month 24 Day
Date of IRB	2021 Year 06 Month 04 Day
Anticipated trial start date	2021 Year 06 Month 04 Day
Last follow-up date	2022 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	2021 Year 11 Month 11 Day
Last modified on	2022 Year 05 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052553