UMIN-CTR Clinical Trial

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
Email	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
Email	n-3104@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053794