UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047159 |
|---|---|
| Receipt number | R000053794 |
| Scientific Title | Trends in allogeneic hematopoietic cell transplantation for adult ALL over the past three decades |
| Date of disclosure of the study information | 2022/03/12 |
| Last modified on | 2022/11/01 09:44:36 |
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Basic information
Public title
Trends in allogeneic hematopoietic cell transplantation for adult ALL over the past three decades
Acronym
Trends in allo-HCT for ALL over the three decades
Scientific Title
Trends in allogeneic hematopoietic cell transplantation for adult ALL over the past three decades
Scientific Title:Acronym
Trends in allo-HCT for ALL over the three decades
Region
| Japan |
Condition
Condition
Acute lymphoblastic leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the transition of allogeneic transplantation results of ALL in Japan over time
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival according to disease stage and transplant periods
Key secondary outcomes
1. Relapse rate and non-relapse mortality according to disease stage and transplant periods
2. Risk factors for survival, relapse, or non-relapse mortality
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent allogeneic hematopoietic cell transplantation for ALL between 1990 and 2019
Key exclusion criteria
Patients who did not agree to participate in this study
Target sample size
8500
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
466-8560
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
466-8560
Address
65 Tsurumai-cho Sho-waku
TEL
052-744-2942
Homepage URL
n-3104@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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 Institutional Review Board
Address
65 Tsurumai-cho Showa-ku, Nagoya
Tel
052-744-2423
ethics@med.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
| 2022 | Year | 03 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35737870/
Number of participants that the trial has enrolled
8467
Results
Allo-HCT outcomes for adults with ALL have improved over the past 30 years. Non-relapse mortality was improved regardless of Philadelphia chromosome (Ph) status and disease status. Although there were continual improvements in adjusted survival for Ph-positive patients, the improvement was inadequate for Ph- patients with t(4;11), t(8;14), t(14;18), or hypodiploidy.
Results date posted
| 2022 | Year | 11 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 08 | Month | 04 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 11 | Month | 01 | Day |
Other
Other related information
Analyze data of patients who underwent allogeneic hematopoietic cell transplantation between 1990-2019 using TRUMP registry
Management information
Registered date
| 2022 | Year | 03 | Month | 12 | Day |
Last modified on
| 2022 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053794
