UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022684 |
|---|---|
| Receipt number | R000026143 |
| Scientific Title | Nationwide survey of HLA haploidentical stem cell transplantation with post-transplantation cyclophosphamide |
| Date of disclosure of the study information | 2016/06/09 |
| Last modified on | 2019/02/12 14:19:39 |
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Basic information
Public title
Nationwide survey of HLA haploidentical stem cell transplantation with post-transplantation cyclophosphamide
Acronym
AMED PTCY 16
Scientific Title
Nationwide survey of HLA haploidentical stem cell transplantation with post-transplantation cyclophosphamide
Scientific Title:Acronym
AMED PTCY 16
Region
| Japan |
Condition
Condition
Patients receiving HLA haploidentical stem cell transplantation with post-transplantation cyclophosphamide
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate patients receiving HLA haploidentical stem cell transplantation with post-transplantation cyclophosphamide in Japan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
Key secondary outcomes
1. Engraftment
2. The incidence and severity of acute and chronic GVHD
3. Non-relapse mortality
4. The incidence of relapse
5. Disease-free survival
6. Dose and Timing of post-transplantation cyclophosphamide
7. The proportion of patients who need dose reduction or stop of post-transplantation cyclophosphamide
8. Immunosuppressive drugs except for post-transplantation cyclophosphamide
9. The proportion of patients who stopped immunosuppressive drugs within 1 year.
10. The incidence of cardiac toxicity from post-transplantation cyclophosphamide
11. The incidence of hemorrhagic cystitis
12. The incidence of complications associated with haploimmunostorm syndrome
13. The incidence of donor cell-derived hematological malignancies
14. Medical care cost and duration of hospital stay
15. Subgroup analysis according to stem cell source, conditioning regimen, and GVHD prophylaxis
16. Subgroup analysis according to disease risk index (DRI)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who receive HLA-haploidentical stem cell transplantation between 2012 and 2015
Key exclusion criteria
Not applicable
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanori Teshima |
Organization
Hokkaido University Hospital
Division name
Department of Hematology
Zip code
Address
N15 W7, Kita-Ku, Sapporo 060-8638
TEL
011-706-7214
sugitaj@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Sugita |
Organization
Hokkaido University Hospital
Division name
Department of Hematology
Zip code
Address
N15 W7, Kita-Ku, Sapporo 060-8638
TEL
011-706-7214
Homepage URL
sugitaj@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
the Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2016 | Year | 06 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
multicenter retrospective study
Management information
Registered date
| 2016 | Year | 06 | Month | 09 | Day |
Last modified on
| 2019 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026143
| 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 |
