UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017644 |
|---|---|
| Receipt number | 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 09:20:45 |
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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
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
hshimada@a5.keio.jp
Sponsor or person
Institute
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020394
