Unique ID issued by UMIN | UMIN000041798 |
---|---|
Receipt number | R000047719 |
Scientific Title | POlymorphisms of Killer immunoglobulin-like receptor which affect Stop Tyrosine kinase Inhibitor in patients with Chronic myeloid leukemia: POKSTIC; mutlticenter collaborative observational study |
Date of disclosure of the study information | 2020/09/16 |
Last modified on | 2024/03/18 19:07:37 |
POlymorphisms of Killer immunoglobulin-like receptor which affect Stop Tyrosine kinase Inhibitor in patients with Chronic myeloid leukemia: POKSTIC; mutlticenter collaborative observational study
POKSTIC study
POlymorphisms of Killer immunoglobulin-like receptor which affect Stop Tyrosine kinase Inhibitor in patients with Chronic myeloid leukemia: POKSTIC; mutlticenter collaborative observational study
POKSTIC study
Japan |
Chronic Myeloid Leukemia
Hematology and clinical oncology |
Malignancy
YES
We investigate clinical impact of polymorphisms of killer immunoglobulin-like receptor and human leukocyte antigen for treatment free remission in patients with chronic myeloid leukemia.
Others
We investigate patients who were previously enrolled in three TKI discontinuation trials (DADI, DOMEST and first-line DADI).
Exploratory
Pragmatic
Not applicable
Polymorphisms of KIR for TFR
Polymorphisms of HLA for TFR
Haplotypes (KIR and HLA) for TFR
Polymorphisms of KIR and features of anti-tumor immunity
Observational
15 | years-old | <= |
Not applicable |
Male and Female
Patients who were previously enrolled in TKI discontinuation trials (DADI, DOMEST and first-line DADI) and regularly observed.
Patients who give informed consent.
Patients who can not give informed consent.
Patients who were defined as appropriate by attending physician.
150
1st name | Kimura |
Middle name | |
Last name | Shinya |
Saga University
Division of Hematology, Respiratory Medicine and Oncology, Faculty of Medicine,
859-8501
5-1-1, Nabeshima Saga-city Saga, Japan
0952-34-2366
shkimu@cc.saga-u.ac.jp
1st name | Ureshino |
Middle name | |
Last name | Hiroshi |
Saga University
Division of Hematology, Respiratory Medicine and Oncology, Faculty of Medicine,
859-8501
5-1-1, Nabeshima Saga-city Saga, Japan
0952-34-2366
sr0795@cc.saga-u.ac.jp
Division of Hematology, Respiratory Medicine and Oncology, Faculty of Medicine, Saga University
Bristol Myers Squibb
Other
Saga University
5-1-1, Nabeshima, Saga-city, Saga, Japan
0952-34-2366
kenkyu-shinsei@ml.cc.saga-u.ac.jp
NO
2020 | Year | 09 | Month | 16 | Day |
https://doi.org/10.1016/j.bneo.2024.100001
Published
https://doi.org/10.1016/j.bneo.2024.100001
76
Seventy six patients enrolled.
2022 | Year | 10 | Month | 02 | Day |
Depending on blood sample collection and IRB approval at each institute.
2024 | Year | 03 | Month | 06 | Day |
Patients with CML-CP.
76 patients were enrolled. The median age was 63 years. A total 55.3% (95%CI, 43.4 to 65.6%) CML-CP patients discontinued TKIs. Univariate and multivariate analysis showed KIR3DL1 with ligand for HLA-Bw4 (except when Bw4 80I was HLA-A 24:02 only) was associated with higher molecular relapse (HR, 2.206 (95% CI, 1.112 to 4.376, p=0.024). Notably, these patients had significantly lower NK cell fraction (CD16/56 cells, median 499.63 /micro liter vs 629.17/micro liter, p=0.049).
No AE was observed.
Variables for treatment-free remission.
None.
None.
Completed
2020 | Year | 01 | Month | 29 | Day |
2020 | Year | 04 | Month | 06 | Day |
2020 | Year | 04 | Month | 06 | Day |
2022 | Year | 12 | Month | 31 | Day |
2023 | Year | 02 | Month | 01 | Day |
2023 | Year | 03 | Month | 01 | Day |
2023 | Year | 09 | Month | 30 | Day |
Observational study
Publication for BLOOD neoplasia 2024
2020 | Year | 09 | Month | 15 | Day |
2024 | Year | 03 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047719
Research Plan | |
---|---|
Registered date | File name |
2023/09/28 | (FIX)CML-KIRstudy_Protocol_Tracked.docx |
Research case data specifications | |
---|---|
Registered date | File name |
2023/09/28 | POKSTIC試験データ仕様書.docx |
Research case data | |
---|---|
Registered date | File name |
2023/09/28 | POKSTIC UMIN up用.xlsx |