UMIN-CTR Clinical Trial

Basic information
Public title	A Phase II Study of Chemotherapy Combined with Tyrosine Kinase Inhibitors for Children with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (JPLSG ALL-Ph13).
Acronym	A Phase II Study of Chemotherapy with TKI for Children with Ph+ALL (JPLSG ALL-Ph13).
Scientific Title	A Phase II Study of Chemotherapy Combined with Tyrosine Kinase Inhibitors for Children with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (JPLSG ALL-Ph13).
Scientific Title:Acronym	A Phase II Study of Chemotherapy with TKI for Children with Ph+ALL (JPLSG ALL-Ph13).
Region	Japan

Condition
Condition	Childhood Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Classification by specialty	Hematology and clinical oncology Pediatrics Child
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess a efficacy and safety of a BFM2000 HR backbone chemotherapy combined with tyrosine kinase inhibitor for childhood Philadelphia positive acute lymphoblastic leukemia in Japan.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Three years event free survival
Key secondary outcomes

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	Chemotherapy combined with imatinib or dasatinib.
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	19 years-old >=
Gender	Male and Female
Key inclusion criteria	1) diagnosis of Ph+ALL 2) age between 1 and 19 years old 3) ECOG performance status (PS) score of 0-3 4) no history of previous chemotherapy or radiation therapy 5) written informed consent obtained from patient or guardians.
Key exclusion criteria	1) uncontrolled infection, including active tuberculosis and positive of HIV antibody. 2) pregnancy or high possibility of pregnancy and giving suck wiman. 3) history of congenital or acquired immunodeficiency. 4) any inappropriate status judged by physician.
Target sample size	44

Research contact person
Name of lead principal investigator	1st name Hirohide Middle name Last name Kawasaki
Organization	Kansai Medical University
Division name	Department of Pediatrics
Zip code	573-1010
Address	2-5-1 Shinmachi, Hirakata, Osaka
TEL	072-804-0101
Email	kawasaki@hirakata.kmu.ac.jp

Public contact
Name of contact person	1st name Hirohide Middle name Last name Kawasaki
Organization	Kansai Medical University
Division name	Department of Pediatrics
Zip code	573-1010
Address	2-5-1 Shinmachi, Hirakata, Osaka
TEL	072-804-0101
Homepage URL
Email	kawasaki@hirakata.kmu.ac.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	Non profit foundation
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Kansai Medical University
Address	Department of Pediatrics
Tel	072-804-0101
Email	kawasaki@hirakata.kmu.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	2013 Year 10 Month 02 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	Open public recruiting
Date of protocol fixation	2013 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2013 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 10 Month 02 Day
Last modified on	2019 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013952