UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029171 |
|---|---|
| Receipt number | 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 00:47:26 |
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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
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
keikato-ind@umin.ac.jp
Sponsor or person
Institute
Japan Pediatric Leukemia Lymphoma Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032481
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
