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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001742
Receipt No. R000002099
Scientific Title Treatment protocol for acute promyelocytic leukemia -FBMTG-APL2009-
Date of disclosure of the study information 2009/03/01
Last modified on 2019/03/09

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Basic information
Public title Treatment protocol for acute promyelocytic leukemia
-FBMTG-APL2009-
Acronym FBMTG-APL2009
Scientific Title Treatment protocol for acute promyelocytic leukemia
-FBMTG-APL2009-
Scientific Title:Acronym FBMTG-APL2009
Region
Japan

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

Objectives
Narrative objectives1 We plan the risk-adjusted treatment protocol for adult acute promyelocytic leukemia. The risks are determined by the MRD status post consolidation treatment.
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, treatment-related toxicities

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-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 Maneuver
Interventions/Control_1 APL patients who present white blood cell count > 3,000 on admission, will receive high-dose of cytarabine plus intrathecal injection in addition to conventional chemotherapy plus ATRA therapy at the consolidation chemotherapy.
Interventions/Control_2 APL patients who present white blood cell count < 3,000 on admission, will receive conventional chemotherapy combined with ATRA therapy.
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
65 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; T.Bil equal to or less than 2.0mg/dL, Cr equal to or less than 2.0mg/dL
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 Tomohiko Kamimura
Organization Harasanshin General Hospital
Division name Department of Hematology
Zip code
Address 1-8 Taihaku-cho, Hakata-ku, Fukuoka 812-0033, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiro Miyamoto
Organization Kyushu University Hospital
Division name Hematology/ Oncology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5230
Homepage URL
Email toshmiya@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute Fukuoka Blood & Marrow Transplant Group
Institute
Department

Funding Source
Organization Fukuoka Blood & Marrow Transplant Group
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
2009 Year 03 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 Completed
Date of protocol fixation
2009 Year 02 Month 18 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2019 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 02 Month 28 Day
Last modified on
2019 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002099

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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