UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Treatment protocol for acute promyelocytic leukemia -FBMTG-APL2009-
Title of the study (Brief title)	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	Tomohiko Kamimura
Organization	Harasanshin General Hospital
Division name	Department of Hematology
Address	1-8 Taihaku-cho, Hakata-ku, Fukuoka 812-0033, Japan
TEL
Email

Public contact
Name of contact person	Toshihiro Miyamoto
Organization	Kyushu University Hospital
Division name	Hematology/ Oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 02 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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