UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052420 |
|---|---|
| Receipt number | R000059745 |
| Scientific Title | Meta-analysis of the safety of Chimeric Antigen Receptor (CAR) T-Cell Therapy for hematological malignancies |
| Date of disclosure of the study information | 2023/10/05 |
| Last modified on | 2024/04/04 10:37:39 |
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Basic information
Public title
Meta-analysis of the safety of Chimeric Antigen Receptor (CAR) T-Cell Therapy for hematological malignancies
Acronym
Meta-analysis of the safety of Chimeric Antigen Receptor (CAR) T-Cell Therapy for hematological malignancies
Scientific Title
Meta-analysis of the safety of Chimeric Antigen Receptor (CAR) T-Cell Therapy for hematological malignancies
Scientific Title:Acronym
Meta-analysis of the safety of Chimeric Antigen Receptor (CAR) T-Cell Therapy for hematological malignancies
Region
| Japan |
Condition
Condition
Hematological Malignancies
Classification by specialty
| Medicine in general | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Chimeric antigen receptor T-cell (CAR-T) therapy is one of the newer forms of cancer treatment, and it is an innovative approach for utilizing immune cells to attack cancer cells. Used specifically to treat multiple myeloma, lymphoma, and acute lymphoblastic leukemia, six products (Tisagenlecleucel, Axicabtagene ciloleucel, Brexucabtagene autoleucel, Lisocabtagene maraleucel, Idecabtagene vicleucel and Ciltacabtagene autoleucel) are currently approved by the US FDA. However, some significant toxicities pose a major challenge to CAR-T therapy. Therefore, in a comprehensive analysis of data from randomized controlled trials (RCTs), we will conduct a systematic review and meta-analysis to examine adverse events among products regarding CAR-T therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the frequency of occurrence of cytokine release syndrome and neurotoxicity during the observation period.
Key secondary outcomes
Secondary outcomes are the frequency of infections, hypogammaglobulinemia, infusion reactions, cytopenia, macrophage activation syndrome/hemophagocytic syndrome, coagulopathy, and tumor lysis syndrome over the observation period.
Base
Study type
Others,meta-analysis etc
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
Only parallel-group RCTs will be included, and only English-language literature will be included. Include short reports and conference abstracts. Non-inferiority trials are acceptable alongside superiority trials. RCTs of any phase may be included. Exclude trials that do not report safety data.
The main inclusion criteria are as follows.
(1) Trials in adult patients with hematological malignancies.
(2) RCTs including CAR-T therapy and control therapy.
(3) Trials with adverse event results (cytokine release syndrome, neurotoxicity, infection, hypogammaglobulinemia, infusion reaction, cytopenia, macrophage activation syndrome/hemophagocytic lymphohistiocytosis, coagulopathy, tumor lysis syndrome).
Key exclusion criteria
(1) Systematic review or meta-analysis articles.
(2) Retrospective analysis.
(3) Single prospective cohort study without a control group.
(4) Non-RCT.
(5) The republished research literature is excluded unless the research includes new findings related to adverse events listed in inclusion criteria.
(6) Trials with no or insufficient safety outcomes at the time of the literature search.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Takase-Minegishi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem Cell and Immune Regulation
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2630
kaoru_t@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Minegishi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem Cell and Immune Regulation
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2630
Homepage URL
kaoru_t@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
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
Yokohama City University Graduate School of Medicine
Address
Yokohama City University Graduate School of Medicine
Tel
045-787-2630
kaoru_t@yokohama-cu.ac.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
| 2023 | Year | 10 | Month | 05 | 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
| 2023 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will search for candidate articles using PubMed, Cochrane, EMBASE, and Web of Science Core Collection in October 2023. A hand search will be conducted by two investigators.
RCTs meeting the following criteria will be considered for inclusion:
Participants: Adult patients with hematological malignancies.
Intervention: Treatment with CAR-T therapy.
Comparison: Control treatment.
Outcomes: To collect the overall incidence of adverse events during the observation period.
Quality assessment:
The risk of bias of each study will be assessed by Cochrane risk of bias (RoB) tool for RCTs.
Subgroup analysis:
Subgroup analyses based on products will be performed.
Management information
Registered date
| 2023 | Year | 10 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059745
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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