UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013144 |
|---|---|
| Receipt number | R000014906 |
| Scientific Title | prospective study for treatment strategies after the decision of allogeneic HSCT in patients with MDS (KSGCT1303/ MDS-prospective) |
| Date of disclosure of the study information | 2014/02/13 |
| Last modified on | 2019/04/25 10:14:28 |
* 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
prospective study for treatment strategies after the decision of allogeneic HSCT in patients with MDS
(KSGCT1303/ MDS-prospective)
Acronym
KSGCT1303 / MDS-prospective
Scientific Title
prospective study for treatment strategies after the decision of allogeneic HSCT in patients with MDS
(KSGCT1303/ MDS-prospective)
Scientific Title:Acronym
KSGCT1303 / MDS-prospective
Region
| Japan |
Condition
Condition
myelodysplastic syndromes (MDS)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the effect of treatment strategies after the decision of allogeneic HSCT in patients with MDS prospectively
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1-year overall survival after the registration
Key secondary outcomes
1)the rate of patients who actually receive HSCT within 1 year after the registration
2)1-year overall survival after HSCT
3)1-year progression-free survival after HSCT
4)non-relapse mortality after HSCT, relapse rate after HSCT
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
1.Patients with MDS according to FAB classification or AML secondary to MDS.
2.Patients who decided to undergo HSCT.
3.Patients who are more than 16 years old.
4. Patients who had received any kind of prior treatment other than HSCT will be included. Any kind of HSCT and post-transplantation treatment are allowed.
Key exclusion criteria
1.Patients with treatment-related MDS.
2.Patients who had received HSCT.
3.Patients who do not provide written informed consent.
Target sample size
100
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
| 2014 | Year | 02 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2014 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
to evaluate the effect of treatment strategies after the decision of allogeneic HSCT in patients with MDS prospectively
Management information
Registered date
| 2014 | Year | 02 | Month | 12 | Day |
Last modified on
| 2019 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014906
