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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025044
Receipt No. R000028820
Scientific Title Treatment protocol for acute promyelocytic leukemia FBMTG APL2017
Date of disclosure of the study information 2017/01/01
Last modified on 2017/07/28

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Basic information
Public title Treatment protocol for acute promyelocytic leukemia
FBMTG APL2017
Acronym FBMTG APL2017
Scientific Title Treatment protocol for acute promyelocytic leukemia
FBMTG APL2017
Scientific Title:Acronym FBMTG APL2017
Region
Japan

Condition
Condition acute promyelocytic leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine efficacy and safety of therapy which consisted with ATRA combined with ATO in early stage as induction therapy for acute promyelocytic leukemia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 3 years disease-free survival
Key secondary outcomes 5 years disease free survival
CR rate
Perfection rate of protocol regimen
treatment-related toxicities
Incidence rate of differentiation syndrome
Frequency of additional administration of idarubicune
Frequency of mutation in PML-RARA fusion gene and its influence for therapy efficacy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Induction:ATRA 45mg/m2 2-3x po day1-max day74
Consolidation:ATO 0.15mg/kg div day15-max day74
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
15 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Acute promyelocytic leukemia by WHO classification
2. The first time treatment example which does not catch chemotherapy or the radiotherapy
3. The case that is equal to or less than 65 years old more than age 15 years old
4. Performance status 0-2
5. A case without the dangerously ill internal organs disorder
6. The case that an agreement by the document is provided from a patient on explanation because of final examination contents
Key exclusion criteria 1. The case having double cancers
2. The case with an infectious disease having difficulty with control
3. The case with a severe mental disorder
4. The pregnancy or breast-feeding woman
5. The case that the medical attendant judged to be inappropriate
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken takase
Organization National Hospital Organization Kyushu Medical Center
Division name Department of Hematology
Zip code
Address 1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan
TEL 092-852-0700
Email fbmtg@intmed1.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name FBMTG Study Office
Organization FBMTG
Division name FBMTG Study Office
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5315
Homepage URL
Email fbmtg@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute FBMTG
Institute
Department

Funding Source
Organization Research Foundation for Community Medicine
Organization
Division
Category of Funding Organization Non profit foundation
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
2017 Year 01 Month 01 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
2016 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 29 Day
Last modified on
2017 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028820

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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