UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006071 |
|---|---|
| Receipt number | R000007182 |
| Scientific Title | Allogeneic hematopoietic stem cell transplantation for aplastic anemia using low-dose anti-thymocyte globulin |
| Date of disclosure of the study information | 2011/08/31 |
| Last modified on | 2023/06/08 19:54:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Allogeneic hematopoietic stem cell transplantation for aplastic anemia using low-dose anti-thymocyte globulin
Acronym
HSCT for AA using low-dose ATG
Scientific Title
Allogeneic hematopoietic stem cell transplantation for aplastic anemia using low-dose anti-thymocyte globulin
Scientific Title:Acronym
HSCT for AA using low-dose ATG
Region
| Japan |
Condition
Condition
SAA
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of allogeneic HSCT for aplastic anemia using fludarabine, cyclophosphamide, and low-dose ATG
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
1-year overall survival
Key secondary outcomes
engraftment rate, rate of grade II-IV acute GVHD, rate of chronic GVHD, rate of mixed chimerism, rate of CMV disease, rate of PTLD
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Conditioning regimen
Fludarabine
30mg/m2/day iv day-6,-5,-4,-3
Cyclophosphamide
25mg/kg/day iv day-6,-5,-4,-3
ATG(thymoglobulin)
1.25mg/kg iv day-4,-3
In case of HSCT from unrelated donor or HLA-mismatched related donor,
TBI 2Gy day-1 will be added.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria
1. Patients with severe acquired aplastic anemia
2. Patients who had received any kind of prior treatment other than HSCT will be included.
3. Patients who are 20 to 65 years old
4. Patients who have HLA matched related donor, single antigen mismatched related donor, HLA matched unrelated donor, and single DRB1 allele mismatched unrelated donor.
5. Patients in performance status of 0 or 1.
6. Patients whose major organ functions are preserved.
7. Patients from whom informed consent are obtained
Key exclusion criteria
Exclusion criteria
1. Patients with poorly controlled DM
2. Patients with poorly controlled hypertension
3. Patients with poorly controlled active infection
4. Patients with chromosome 7 abnormality
5. Patients with coexistence of malignancy
6. Patients who are pregnant or nursing
7. Patients with serious mental disorder
8. Patients with HBs antigen or HBe antigen positive
9. Patients with HIV antibody positive
10. Patients who are allergic to drugs used in conditioning regimen
11. Patients who had undergone allogeneic HSCT
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Okamoto |
Organization
Kanto Study Group for Cell Therapy
Division name
Chairman
Zip code
Address
Tokyo
TEL
03-6225-2040
ksgctdc@ksgct.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Kako |
Organization
Kanto Study Group for Cell Therapy
Division name
Trial Office
Zip code
Address
Saitama
TEL
048-647-2111
Homepage URL
shinichikako@asahi-net.email.ne.jp
Sponsor or person
Institute
Kanto Study Group for Cell Therapy
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2011 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://ash.confex.com/ash/2018/webprogram/Paper115105.html
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
| 2011 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 16 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 05 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 09 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 29 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007182
