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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011946
Receipt No. R000013952
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).
Date of disclosure of the study information 2013/10/02
Last modified on 2019/10/07

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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/ctr_e/ctr_view.cgi?recptno=R000013952

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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