UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041967 |
|---|---|
| Receipt number | R000047907 |
| Scientific Title | Prognostic factor analysis by integrating JALSG clinical trials using TKIs for Ph+ALL with TRUMP data |
| Date of disclosure of the study information | 2020/10/07 |
| Last modified on | 2022/06/30 18:02:59 |
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Basic information
Public title
Prognostic factor analysis by integrating JALSG clinical trials using TKIs for Ph+ALL with TRUMP data
Acronym
JALSG Ph+ALL TKI-SCT study
Scientific Title
Prognostic factor analysis by integrating JALSG clinical trials using TKIs for Ph+ALL with TRUMP data
Scientific Title:Acronym
JALSG Ph+ALL TKI-SCT study
Region
| Japan |
Condition
Condition
Philadelphia chromosome-positive acute lymphoblastic leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify prognostic factors in Ph+ALL patients who treated with tyrosine kinase inhibitors.
Basic objectives2
Others
Basic objectives -Others
Identification of prognostic factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify risk factors for overall survival
Key secondary outcomes
- To identify risk factors for relapse
- To identify risk factors for non-relapse mortality
- To identify prognostic factors in allogenic hematopoietic cell transplantation
- To identify prognostic factors in non-transplant patients
- Survival rate, relapse rate, and non-relapse mortality according to identified factors
- Indication of allogeneic hematopoietic cell transplantation in the first complete remission
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
| 15 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have enrolled in the JALSG Ph+ALL202 study, 208 study, or 213 study
Key exclusion criteria
Patients rejected the enrollment
Target sample size
246
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Nishiwaki |
Organization
Nagoya University Hospital
Division name
Department of Advanced Medicine
Zip code
4668560
Address
65 Tsurumai-cho Showa-ku, Nagoya
TEL
052-744-2942
n-3104@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Nishiwaki |
Organization
Nagoya University Hospital
Division name
Department of Advanced Medicine
Zip code
4668560
Address
65 Tsurumai-cho Showa-ku, Nagoya
TEL
052-744-2942
Homepage URL
n-3104@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Hospital
Address
65 Tsurumai-cho Showa-ku, Nagoya
Tel
052-744-2061
iga-shinsa@adm.nagoya-u.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
| 2020 | Year | 10 | Month | 07 | 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
206
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pooled analysis of JALSG Ph+ALL202 study, Ph+ALL208 study, and Ph+ALL213 study.
Management information
Registered date
| 2020 | Year | 10 | Month | 01 | Day |
Last modified on
| 2022 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047907
| 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 |
