UMIN-CTR Clinical Trial

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

Chronic Myeloid Leukemia (CML)

Classification by specialty

Hematology and clinical oncology

Pediatrics

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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