UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052477 |
|---|---|
| Receipt number | R000059762 |
| Scientific Title | NARUHAYA: New Approach of Related and Unrelated Hematopoietic stem cell transplantation for Advanced myelodysplastic syndrome to Yield Amazing outcomes |
| Date of disclosure of the study information | 2023/10/13 |
| Last modified on | 2023/10/12 17:19:09 |
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Basic information
Public title
Prospective study for early allogeneic hematopoietic stem cell transplantation in patients with advanced MDS
Acronym
NARUHAYA study
Scientific Title
NARUHAYA: New Approach of Related and Unrelated Hematopoietic stem cell transplantation for Advanced myelodysplastic syndrome to Yield Amazing outcomes
Scientific Title:Acronym
NARUHAYA study
Region
| Japan |
Condition
Condition
advanced myelodysplastic syndrome
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to prospectively evaluate the efficacy of early transplantation, which is performed within 90 days from the registration of this study, in patients with advanced MDS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3-year overall survival after the registration
Key secondary outcomes
1)the rate of patients who actually receive HSCT within 90 days from the registration
2)3-year overall survival after HSCT
3)3-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 de novo or therapy-related MDS according to WHO classification.
2.MDS patients with Intermediate-2 or High in IPSS and/or Intermediate, High or Very High in IPSS-R.
3.Patients who are planned to receive allogeneic transplantation within 90 days from the registration of this study.
4.Patients who can participate in this study immediately after the decision for HSCT.
5.Patients who are more than 15 years old.
Key exclusion criteria
1. Patients who have 20% or more than 20% of blast in BM or PB.
2. Patients who have had received azacitidine or AML-type chemotherapy for MDS.
3. Patients who have received allogeneic transplantation.
4. Patients who do not provide written informed consent.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Kanda |
Organization
Kanto Study Group for Cell Therapy
Division name
Chairman
Zip code
186-0004
Address
2F North, 1-8-33, Naka, Kunitachi-shi, Tokyo
TEL
042-505-4251
ksgctdc@ksgct.net
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Kako |
Organization
Jichi Medical University Saitama Medical Center
Division name
Division of Hematology
Zip code
330-8503
Address
1-847, Amanuma-cho, Omiya-ku, Saitama-shi, 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
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of Jichi Medical University Saitama Medical Center
Address
1-847, Amanuma-cho, Omiya-ku, Saitama-shi, Saitama
Tel
048-647-2111
daisaki.miho@jichi.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
| 2023 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2029 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study to evaluate the efficacy of allogeneic stem cell transplantation which is performed within 90 days from the study enrollment for patients with advanced MDS.
The primary outcome measure is overall survival at 3 years from the study enrollment.
Management information
Registered date
| 2023 | Year | 10 | Month | 12 | Day |
Last modified on
| 2023 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059762
| Research Plan | |
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| 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 |
