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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013144
Receipt No. 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

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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
Email 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
Email shinichikako@asahi-net.email.ne.jp

Sponsor
Institute Kanto Study Group for Cell Therapy
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014906

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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