UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001742 |
|---|---|
| Receipt number | 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 10:50:17 |
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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
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
toshmiya@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Fukuoka Blood & Marrow Transplant Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002099
