UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Pilot Study of Dasatinib for Relapsed or Refractory ABL1/PDGFRB Rearrangemennt Positive Ph-like Acute Lymphoblasic Leukemia
Title of the study (Brief title)	D-APPLE STUDY
Region	Japan

Condition
Condition	ABL1/PDGFRB Rearrangemennt Positive Ph-like Acute Lymphoblasic Leukemia
Classification by specialty	Hematology and clinical oncology Pediatrics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To collect basic data of Dasatinib for the cases with primary refractory or recurrent ABL1/PDGFRB rearrangement positive Ph-like ALL focusing on its efficacy and safety
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Toxic effects of dasatinib at the dose of 60 mg per square meter body surface area
Key secondary outcomes	- decay rate of blasts in peripheral blood - decay rate of blasts in bone-marrow blood - achievement rate of complete remission - PK study of dasatinib - TKI sensitivity test in vitro

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Taking orally of Dasatinib 60mg per square meter body surface area once a day for two weeks
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	1 years-old <=
Age-upper limit	20 years-old >=
Gender	Male and Female
Key inclusion criteria	1) primary refractory or relapsed ALL 2) ABL1 or PDGFRB Rearrangemennt is confirmed by FISH or PCR method 3) relapsed cases: over 25% blasts in bone-marrow at the time of study enrollment refractory cases: over 5% blasts in bone-marrow at the time of study enrollment 4) without history of previous chemotherapy after diagnosis of primary refractory or relapse (other than steroids within 10 days or intrathecal infusion) 5) Age 1 year to 20 years old at the time of study enrollment 6) ECOG performance status (PS) score of 0-2 7) Patients must have sufficient organ function 8) All patients and/or their parents or legal guardians must sign a written informed consent
Key exclusion criteria	1) Patients with severe CNS or gastrointestinal hemorrhage (grade 2 or higher in CTCAE ver4.0) 2) Patients with severe fluid retention (grade 2 or higher in CTCAE ver4.0) 3) QTc is more than 0.45 seconds 4) Patients with uncontrollable infection (including those with active tuberculosis or positive HIV antibody) 5) Patient with a history of organ transplantation other than stem cell transplantation 6) Patient with uncontrollable diabetes mellitus 7) Patients with history of primary or acquired immunodeficiency 8) Patients who are pregnant 9) Patient with 21-trisomy 10) Patient with severe mental retardation 11) Patients with any other inappropriate status judged by physician
Target sample size	3

Research contact person
Name of lead principal investigator	Tomoo Osumi
Organization	National Center for Child Health and Development
Division name	Division of Leukemia and lymphoma, Children's Cancer Center
Address	2-10-1 Okura Setagaya-ku Tokyo,157-8535 Japan
TEL	03-3416-0181
Email	osumi-t@ncchd.go.jp

Public contact
Name of contact person	Tomoo Osumi
Organization	National Center for Child Health and Development
Division name	Division of Leukemia and lymphoma, Children's Cancer Center
Address	2-10-1 Okura Setagaya-ku Tokyo,157-8535 Japan
TEL	03-3416-0181
Homepage URL
Email	osumi-t@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	- Japan Leukemia Research Fund - Children's Cancer Association of Japan
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

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	国立成育医療研究センター（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 10 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 02 Month 09 Day
Anticipated trial start date	2015 Year 02 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 02 Month 09 Day
Last modified on	2016 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018571