UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049407 |
|---|---|
| Receipt number | R000056259 |
| Scientific Title | Prospective observational study on the impact of vaccination against COVID-19 in patients with hematopoietic tumors |
| Date of disclosure of the study information | 2022/11/02 |
| Last modified on | 2025/11/04 10:39:17 |
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Basic information
Public title
Prospective observational study on the impact of vaccination against COVID-19 in patients with hematopoietic tumors
Acronym
Prospective observational study on the impact of vaccination against COVID-19 in patients with hematopoietic tumors
Scientific Title
Prospective observational study on the impact of vaccination against COVID-19 in patients with hematopoietic tumors
Scientific Title:Acronym
Prospective observational study on the impact of vaccination against COVID-19 in patients with hematopoietic tumors
Region
| Japan |
Condition
Condition
hematopoietic tumors
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
After vaccination against COVID-19, blood samples will be collected to determine the percentage of SARS-CoV-2 antibody carriage.
The background of patients with hematopoietic tumors (tumor classification, stage, treatment, etc.) will be examined, including the effect of the vaccine for COVID-19.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SARS-CoV-2 antibody positivity after 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
| 16 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Age 16 years or older at the time of consent
2) Patients with hematopoietic tumors attending or hospitalized at the National Cancer Center Hospital
3) Adults whose written consent for this study has been obtained by the patient or a surrogate.
3) Adults for whom written consent for this study has been obtained by the individual or a surrogate, or minors for whom written consent for this study has been obtained by the individual and a surrogate.
4) Patients with hematopoietic tumors who are receiving or have received the following chemotherapy regimens (a small number of patients with hematopoietic tumors on no treatment or receiving/post receiving other chemotherapy regimens may be included)
B-cell antibody (rituximab/obinutuzumab) and or chemotherapy
CAR-T therapy
Dual-specificity antibody agents
BTK inhibitors
5) Scheduled or post (within 3 months) vaccination with novel coronavirus vaccine
Key exclusion criteria
1) Subjects whom the principal investigator or physician in charge determines are not appropriate for this study
2) Patients after allogeneic hematopoietic stem cell transplantation
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Katsuya |
Organization
National Cancer Center Hospital
Division name
Department of experimental development
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
ykatsuya@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Katsuya |
Organization
National Cancer Center Hospital
Division name
Department of experimental development
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
Homepage URL
ykatsuya@ncc.go.jp
Sponsor or person
Institute
National cancer center hospital
Institute
Department
Personal name
Funding Source
Organization
National cancer center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National cancer center
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel
0335422511
irst@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-583, 2021-345
Org. issuing International ID_1
Natinal cancer center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立がん研究センター中央病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 02 | Day |
Related information
URL releasing protocol
No plans to publish the protocol
Publication of results
Unpublished
Result
URL related to results and publications
Submission in progress
Number of participants that the trial has enrolled
200
Results
Patients with HM may be recommended for vaccination even during active treatment, as the T-cell immune response may be induced COVID-19 from causing severe disease, even in the absence of an antibody response
Results date posted
| 2025 | Year | 11 | Month | 04 | Day |
Results Delayed
Results Delay Reason
None
Date of the first journal publication of results
| 2025 | Year | 07 | Month | 31 | Day |
Baseline Characteristics
Patients with hematologic malignancies (HM) are known to be severely compromised by Coronavirus Disease 2019 (COVID-19). The successful development of the COVID-19 vaccine has reduced the risk of severe disease and death, and the vaccine is widely available throughout the world. However, several studies have shown that patients with HM may not benefit from the vaccine due to lymphocyte suppression therapies. It has been reported that not only antibody responses, but also T-cell immune responses are important in the acquisition of immunity to vaccines, but there are few reports in patients with HM.
Participant flow
In patients with B-cell lymphoma who received B-cell suppressed treatment in our institution, serum antibodies to the SARS-CoV-2 spike protein (S-IgG) were measured after the second and booster (third) mRNA vaccinations; specific T-cell responses to the SARS-CoV-2 vaccine were also measured. T-cell immune responses were detected based on the Enzyme linked immunosorbent spot (ELISPOT) methods.
Adverse events
None
Outcome measures
Forty-six of 114 patients (40%) acquired antibodies, and independent predictors of response were age (<65 years; Odds ratio (OR), 8.99; 95% Confidence Interval (CI), 1.88-43.1; P<0.01) and CD19 count (>50; OR, 19.7; 95% CI, 3.13-123; P<0.01). T-cell responses were also seen in some patients who did not develop antibodies to the vaccine. The booster vaccine enhanced the immune response in both antibody and T-cell responses.
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 11 | Month | 04 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient enrollment completed, preparing for publication
Management information
Registered date
| 2022 | Year | 11 | Month | 02 | Day |
Last modified on
| 2025 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056259
