UMIN-CTR Clinical Trial

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

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Basic information

Public title

POlymorphisms of Killer immunoglobulin-like receptor which affect Stop Tyrosine kinase Inhibitor in patients with Chronic myeloid leukemia: POKSTIC; mutlticenter collaborative observational study

Acronym

POKSTIC study

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

Scientific Title:Acronym

POKSTIC study

Region

Japan


Condition

Condition

Chronic Myeloid Leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

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.

Basic objectives2

Others

Basic objectives -Others

We investigate patients who were previously enrolled in three TKI discontinuation trials (DADI, DOMEST and first-line DADI).

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Polymorphisms of KIR for TFR

Key secondary outcomes

Polymorphisms of HLA for TFR
Haplotypes (KIR and HLA) for TFR
Polymorphisms of KIR and features of anti-tumor immunity


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

15 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who were previously enrolled in TKI discontinuation trials (DADI, DOMEST and first-line DADI) and regularly observed.

Patients who give informed consent.

Key exclusion criteria

Patients who can not give informed consent.

Patients who were defined as appropriate by attending physician.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Kimura
Middle name
Last name Shinya

Organization

Saga University

Division name

Division of Hematology, Respiratory Medicine and Oncology, Faculty of Medicine,

Zip code

859-8501

Address

5-1-1, Nabeshima Saga-city Saga, Japan

TEL

0952-34-2366

Email

shkimu@cc.saga-u.ac.jp


Public contact

Name of contact person

1st name Ureshino
Middle name
Last name Hiroshi

Organization

Saga University

Division name

Division of Hematology, Respiratory Medicine and Oncology, Faculty of Medicine,

Zip code

859-8501

Address

5-1-1, Nabeshima Saga-city Saga, Japan

TEL

0952-34-2366

Homepage URL


Email

sr0795@cc.saga-u.ac.jp


Sponsor or person

Institute

Division of Hematology, Respiratory Medicine and Oncology, Faculty of Medicine, Saga University

Institute

Department

Personal name



Funding Source

Organization

Bristol Myers Squibb

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Saga University

Address

5-1-1, Nabeshima, Saga-city, Saga, Japan

Tel

0952-34-2366

Email

kenkyu-shinsei@ml.cc.saga-u.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

2020 Year 09 Month 16 Day


Related information

URL releasing protocol

https://doi.org/10.1016/j.bneo.2024.100001

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1016/j.bneo.2024.100001

Number of participants that the trial has enrolled

76

Results

Seventy six patients enrolled.

Results date posted

2022 Year 10 Month 02 Day

Results Delayed


Results Delay Reason

Depending on blood sample collection and IRB approval at each institute.

Date of the first journal publication of results

2024 Year 03 Month 06 Day

Baseline Characteristics

Patients with CML-CP.

Participant flow

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).

Adverse events

No AE was observed.

Outcome measures

Variables for treatment-free remission.

Plan to share IPD

None.

IPD sharing Plan description

None.


Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 01 Month 29 Day

Date of IRB

2020 Year 04 Month 06 Day

Anticipated trial start date

2020 Year 04 Month 06 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry

2023 Year 02 Month 01 Day

Date trial data considered complete

2023 Year 03 Month 01 Day

Date analysis concluded

2023 Year 09 Month 30 Day


Other

Other related information

Observational study
Publication for BLOOD neoplasia 2024


Management information

Registered date

2020 Year 09 Month 15 Day

Last modified on

2024 Year 03 Month 18 Day



Link to view the page

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