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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017644
Receipt No. R000020394
Scientific Title The prospective, multicenter Stop Tyrosine Kinase Inhibitor trial of pediatric chronic myeloid leukemia with sustained complete molecular response (STKI-14)
Date of disclosure of the study information 2015/06/01
Last modified on 2019/04/11

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Basic information
Public title The prospective, multicenter Stop Tyrosine Kinase Inhibitor trial of pediatric chronic myeloid leukemia with sustained complete molecular response (STKI-14)
Acronym The prospective, multicenter Stop TKI trial of pediatric CML (STKI-14)
Scientific Title The prospective, multicenter Stop Tyrosine Kinase Inhibitor trial of pediatric chronic myeloid leukemia with sustained complete molecular response (STKI-14)
Scientific Title:Acronym The prospective, multicenter Stop TKI trial of pediatric CML (STKI-14)
Region
Japan

Condition
Condition Chronic Myeloid Leukemia (CML)
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We study the efficacy of tyrosine kinase inhibitor (TKI) discontinuation for the patients less than age of 20 at diagnosis of CML in chronic or accelerated phase who has been maintaining complete molecular remission for two years or more under the treatment of TKI.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Treatment-free remission rate at 12 months
Key secondary outcomes *Cumulative incidence of MMR loss at 12 months after stopping TKI
*Cumulative incidence of CMR loss at 12 months after stopping TKI
*Exploration of the TFR-related factors
*Cumulative incidence of MMR after restarting TKI
*Cumulative incidence of CMR after restarting TKI
*Growth rate at TKI discontinuation, during MMR maintenance, and after restarting TKI
*QOL at TKI discontinuation, during MMR maintenance, and after restarting TKI
*Adverse events at TKI discontinuation, during MMR maintenance, and after restarting TKI

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After sustained CMR for 2 years or more under the treatment of tyrosine kinase inhibitor (TKI) for 3 years or more, TKI treatment is discontinued. In case of MMR loss, the same TKI as before discontinuation is restarted at the same dose.
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
1 years-old <=
Age-upper limit
20 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients with BCR-ABL fusion transcript-positive CML
2) Chronic or accelerated phase at diagnosis
3) Age under 20 years old at diagnosis
4) Regsitered to the JPLSG CHM-14 study
5) The total period of treatment with TKI for 3 years or more
6) CMR maintained for 2 years or more under the treatment of TKI
7) Less than 0.01% of BCR-ABL/ABL mRNA (international scale) within 4 weeks before the registration
9) Sufficient hepatic and renal function satisfying the laboratory data listed below ;
a)T-Bili: within 3x of age adjusted upper-limit of normal range.
b)Creatinine: within 3x of age adjusted upper-limit of normal range.
10) Written informed consent obtained from
patient or guardians

Key exclusion criteria 1) History of blast crisis
2) CNS hemorrage more than grade 3 of CACAE v4.0
3) Uncontrolled infection, including active tuberculosis and positive of HIV antibody.
4) Pregnancy or high possibility of pregnancy and giving suck woman.
5) History of congenital or acquired immunodeficiency.
6) QTfc, corrected by Friderics formula as
QTfc = QT/RR*1/3, is more than 0.45 seconds.
7) Any inappropriate status judged by
physician.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Shimada
Organization Keio University School of Medicine
Division name Department of Pediatrics
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL 03-5363-3816
Email hshimada@a5.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Shimada
Organization Keio University School of Medicine
Division name Department of Pediatrics
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL 03-5363-3816
Homepage URL
Email hshimada@a5.keio.jp

Sponsor
Institute Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 06 Month 01 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 Completed
Date of protocol fixation
2015 Year 04 Month 27 Day
Date of IRB
2015 Year 05 Month 21 Day
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
2018 Year 12 Month 26 Day
Date of closure to data entry
2019 Year 02 Month 28 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 21 Day
Last modified on
2019 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020394

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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