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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009633
Receipt No. 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

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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
Email 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
Email jalsgsc@hama-med.ac.jp

Sponsor
Institute Japan Adult Leukemia Study Group (JALSG)
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011034

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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