UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009633 |
|---|---|
| Receipt number | R000011034 |
| Scientific Title | Randomized trial comparing 7 day and 5 day schedule of azacitidine for high-risk MDS -JALSG MDS212- |
| Date of disclosure of the study information | 2012/12/26 |
| Last modified on | 2018/12/30 13:02:37 |
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Basic information
Public title
Randomized trial comparing 7 day and 5 day schedule of azacitidine for high-risk MDS -JALSG MDS212-
Acronym
JALSG MDS212
Scientific Title
Randomized trial comparing 7 day and 5 day schedule of azacitidine for high-risk MDS -JALSG MDS212-
Scientific Title:Acronym
JALSG MDS212
Region
| Japan |
Condition
Condition
Myelodysplastic syndromes (RAEB and RAEB-t in FAB classification)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Comparison between 5 day schedule of azacitidine treatment with 7 day schedule for high-risk MDS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
2-year overall survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
azacitidine 75mg/m2, 5 days
Interventions/Control_2
azacitidine 75mg/m2, 7 days
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) RAEB or RAEB-t of MDS in FAB classification
(2) Survival more than 3 months is expected
(3) No previous treatment with azacitidine, chemotherapy, transplantation, or lenalidomide
(4) 16-years old or older
(5) No candidate of hematopoietic stem cell transplantation
(6) Performance status (ECOG) 0-2
(7) Enough organ function
(8) With written informed consent
Key exclusion criteria
(1) AML with recurrent cytogenetic abnormality in WHO classification
(2) With active malignancy
(3) DM with poor control
(4) With active infection
(5) Under control with major tranquilizer
(6) Pregnant women
(7) Infection with HBV, HCV, or HIV
(8) Those evaluated ineligible by attending doctors
Target sample size
410
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Miyazaki |
Organization
Nagasaki University Atomic Bomb Disease Institute
Division name
Department of Hematology
Zip code
Address
Sakamoto 1-12-4, Nagasaki 852-8523, JAPAN
TEL
+81-(0)95-819-7111
y-miyaza@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Miyazaki |
Organization
Nagasaki University Atomic Bomb Disease Institute
Division name
Department of Hematology
Zip code
Address
Sakamoto 1-12-4, Nagasaki 852-8523, JAPAN
TEL
+81-(0)95-819-7111
Homepage URL
jalsgsc@hama-med.ac.jp
Sponsor or person
Institute
Japan Adult Leukemia Study Group (JALSG)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare, JAPAN
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
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
| 2012 | Year | 12 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 26 | Day |
Last modified on
| 2018 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011034
| 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 |
