UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029171
Receipt No. R000032481
Scientific Title Retrospective case analysis of childhood Philadelphila chromosome-positive acute lymphoblastic leukemia not enrolled in clinical trials in the tyrosine kinase inhibitor era.
Date of disclosure of the study information 2017/09/19
Last modified on 2017/09/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Retrospective case analysis of childhood Philadelphila chromosome-positive acute lymphoblastic leukemia not enrolled in clinical trials in the tyrosine kinase inhibitor era.
Acronym JPLSG-Ph+ALL Retro
Scientific Title Retrospective case analysis of childhood Philadelphila chromosome-positive acute lymphoblastic leukemia not enrolled in clinical trials in the tyrosine kinase inhibitor era.
Scientific Title:Acronym JPLSG-Ph+ALL Retro
Region
Japan

Condition
Condition Philadelphila 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 reveal therapeutic approach and treatment outcome of children with Philadelphila chromosome-positive acute lymphoblastic leukemia not enrolled in Japan Pediatric Leukemia Study Group (JPLSG) ALL-Ph13 clinical trial in the tyrosine kinase inhibitor era.
Basic objectives2 Others
Basic objectives -Others To address (1) therapy, particularly, tyrosine kinase inhibitor concurrently administered; (2) initial response obtained by induction therapy, particularly , peripheral blood blast count on day 8, bone marrow blast count on day 15, presence or absence of complete remission after induction, and quantitative response of chimeric transcript; (3) adverse effect related treatment, particularly ones related to tyrosine kinase inhibitor; (4) yes or no of hematopoietic stem cell transplantation, and types of donor and pre-conditioning; and (5) treatment outcome on last follow-up.
Trial characteristics_1 Others
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Induction rate defined by chemotherapeutics
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old >
Gender Male and Female
Key inclusion criteria Those who fulfill two conditions as follows are eligible; (1) the patient who were excluded from Japan Pediatric Leukemia Lymphoma Study Group (JPLSG) ALL-B12 study because of diagnosis of Philadelphia chromosome-positive acute lymphoblastic leukemia after entry to JPLSG ALL-B12 study; (2) the patient who were not enrolled in Japan Pediatric Leukemia Lymphoma Study Group (JPLSG) ALL-Ph13 study.
Key exclusion criteria Those who were considered inappropriate for entry to the current investigation by attending physician.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keisuke Kato, M.D.
Organization Ibaraki Children's Hospital
Division name Division of Pediatric Hematology and Oncology, Specialty Care Service, Pediatrics
Zip code
Address Futaba-dai 3-3-1, Mito, 311-4145, Japan
TEL 029-254-1151
Email keikato-ind@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Kato, M.D.
Organization Ibaraki Children's Hospital
Division name Division of Pediatric Hematology and Oncology, Specialty Care Service, Pediatrics
Zip code
Address Futaba-dai 3-3-1, Mito, 311-4145, Japan
TEL 029-254-1151
Homepage URL
Email keikato-ind@umin.ac.jp

Sponsor
Institute Japan Pediatric Leukemia Lymphoma Study Group
Institute
Department

Funding Source
Organization Ibaraki Children's Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 09 Month 19 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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective investigation

Management information
Registered date
2017 Year 09 Month 17 Day
Last modified on
2017 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032481

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.