UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055423 |
|---|---|
| Receipt number | R000063022 |
| Scientific Title | Survey of Chronic Myeloid Leukemia Patients Prescribed TKI(Descriptive study using DPC data) |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2024/09/05 05:25:39 |
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Basic information
Public title
Survey of Chronic Myeloid Leukemia Patients Prescribed TKI(Descriptive study using DPC data)
Acronym
Survey of Chronic Myeloid Leukemia Patients Prescribed TKI(Descriptive study using DPC data)
Scientific Title
Survey of Chronic Myeloid Leukemia Patients Prescribed TKI(Descriptive study using DPC data)
Scientific Title:Acronym
Survey of Chronic Myeloid Leukemia Patients Prescribed TKI(Descriptive study using DPC data)
Region
| Japan |
Condition
Condition
chronic myeloid leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the prescription status of TKI, the occurrence of cardiovascular events, the temporal changes of BCR-ABL1 (IS), and the comorbidities, for each treatment line, in patients with CML.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prescribing patterns of TKI for each treatment line, the occurrence of cardiovascular events at the time of TKI prescription, the temporal transition of BCR-ABL1 (IS) at the time of TKI prescription, and the comorbidities at the time of TKI prescription.
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) Patients who were diagnosed with CML (ICD-10 code C92.1) during the enrollment period and started a prescription of TKI (Imatinib, Dasatinib, Nilotinib)
(2) Patients who had tests for definitive diagnosis (hematologic tumor genetic testing, chromosomal testing) performed before the prescription of TKI
(3) Patients who continued to be diagnosed with CML after the start of the TKI prescription
Key exclusion criteria
(1) Patients who were under 18 years of age at the time of the initiation of the TKI prescription
(2) Patients who were prescribed TKI before the enrollment period
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Yoshitsugu |
| Middle name | |
| Last name | Kojima |
Organization
Otsuka Pharmaceuticals Co., Ltd
Division name
Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan,Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
kojimayo@otsuka.jp
Public contact
Name of contact person
| 1st name | Yoshitsugu |
| Middle name | |
| Last name | Kojima |
Organization
Otsuka Pharmaceutical Co.,Ltd.
Division name
Medical Affairs
Zip code
108-8242
Address
Medical Affairs
TEL
03-6717-1400
Homepage URL
kojimayo@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceuticals Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceuticals Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Otsuka Pharmaceutical Co.,Ltd. Research Department Research Ethics Committee
Address
10-463 Kagasuno Kawachi cho Tokushima city Tokushima
Tel
088-665-2126
Suzuki.Takashi@otsuka.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
| 2024 | Year | 12 | Month | 31 | 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
2113
Results
The total number of cases studied was 2113, with 1381 cases in the first line of treatment (group at each completed treatment line), 550 cases in the second line, 150 in the third line, and 32 in the fourth line and beyond. The occurrence rate of AOE per treatment line was 8.5% (117/1381 cases) in the first line, 12.5% (69/550 cases) in the second line, and 14.7% (22/150 cases) in the third line. An increase in frequency was observed as the treatment line progressed.
Results date posted
| 2024 | Year | 09 | Month | 05 | Day |
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
| 2023 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There were few patients for whom multiple measurements of BCR-ABL1 (IS) were obtained in each treatment line, making it difficult to evaluate temporal changes.
Management information
Registered date
| 2024 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063022
