UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043973 |
|---|---|
| Receipt number | R000050227 |
| Scientific Title | 2-HLA-haplotype-mismatched hematopietic stem cell transplantation |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2021/04/19 20:09:31 |
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Basic information
Public title
Allogeneic hematopoietic stem cell transplantation from a two HLA-haplotype-mismatched family donor for post-transplant relapse/rejection: A prospective phase II study with statistical validation for survival benefit
Acronym
HLA fully mismatched HSCT
Scientific Title
2-HLA-haplotype-mismatched hematopietic stem cell transplantation
Scientific Title:Acronym
2-HLA-haplotype-mismatched HSCT
Region
| Japan |
Condition
Condition
hematologic malignancies relapsing or with rejection after allogeneic hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of 2-HLA-haplotype-mismatched hematopoietic stem cell transplantation with statistical validation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
overall survival at 2 years
Key secondary outcomes
Safety
1) rate of engraftment at day 35
2) acute GVHD within day 100
3) complications (infections, TMA, etc)
4) other AE
5) non-relapse mortality
efficacy
6) relapse rate
7) disease-free survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Allogeneic hematopoietic stem cell transplantation from a two HLA-haplotype-mismatched family donor
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
| 5 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) age 15-65 years old
2) relapse or rejection case after allogeneic HSCT
3) hematologic malignancies mainly acute type leukemia
4) 2-HLA-haplotype-mismatach between patient and donor
Key exclusion criteria
1) serum Cre >2.0 mg/dl
2) serum T-Bil >2.0 mg/dl
3) selum AST and/or ALT >200 U/L
4) EF <45%
5) SpO2 <95% (room air)
6) PS (ECOG score) 3-4
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ikegame |
Organization
Hyogo College of Medicine
Division name
Hematology
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo
TEL
+81798456886
kame@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ikegame |
Organization
Hyogo College of Medicine
Division name
Hematology
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo
TEL
+81798456886
Homepage URL
haplo@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
partially supplied by Hyogo College of Medicine
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
IRB, Hyogo College of Medicine
Address
1-1, Mukogawa-cho, Nishinomiya city, Hyogo, Japan
Tel
+81798456066
rinri@hyo-med.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
| 2021 | Year | 05 | Month | 01 | 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
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 19 | Day |
Last modified on
| 2021 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050227
| 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 |
