UMIN-CTR Clinical Trial

Basic information
Public title	A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Promyelocytic Leukemia (APL)
Acronym	JPLSG AML-P13
Scientific Title	A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Promyelocytic Leukemia (APL)
Scientific Title:Acronym	JPLSG AML-P13
Region	Japan

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

Objectives
Narrative objectives1	To evaluate an efficacy and safety of the treatment strategy consisted of 2 courses of multi-agent chemotherapy followed by 3 courses of consolidation therapy with either ATO and/or GO.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Three-year event-free survival rate
Key secondary outcomes	Remission induction rate Molecular remission rate at the end of consolidation therapy Three-year overall survival rate Rate of DIC, APL-DS, and mortality during first remission induction therapy Rate of adverse events during ATO therapy Rate of adverse events

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	ALL eligible patients receive 2 courses of induction therapy comprising ATRA, cytarabine and anthracyclines. Patients who achieved hematological CR (standard risk group) receive 3 courses of consolidation therapy comprising ATRA and ATO, followed by 1 year of maintenance therapy consist of intermittent ATRA. Patients who did not achieve hematological CR (high risk group) receive 3 courses of consolidation therapy comprising either ATO or GO, followed by 1 year of maintenance therapy consist of 6MP and MTX. Patients with molecular persistence at the end of consolidation therapy (molecular persistence group) receive single-agent reinduction therapy of GO.
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	Not applicable
Age-upper limit	18 years-old >
Gender	Male and Female
Key inclusion criteria	Patient with a diagnosis of APL genetically or cytogenetically diagnosed by either one of three methods; karyotyping, FISH, or RT-PCR. ECOG performance status score of 0-2, or of 3 when caused by leukemia. No previous treatment. Written informed consent obtained either from patient or guardians.
Key exclusion criteria	17q12/RARA not detected genetically and cytogenetically APL with t(11;17)(q23;q12)/PLZF-RARA CNS hemorrhage which is likely to interfere protocol therapy Secondary APL due to previous chemotherapy or radiation therapy Unmanageable infectious disease including tuberculosis Any inappropriate status judged by physician
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Takahashi
Organization	Toho University
Division name	Department of Pediatrics
Zip code	143-8451
Address	6-11-1 Omorinishi, Ota-ku, Tokyo 143-8451
TEL	03(3762)4151
Email	taccn@fb3.so-net.ne.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Takahashi
Organization	Toho University
Division name	Department of Pediatrics
Zip code	143-8451
Address	6-11-1 Omorinishi, Ota-ku, Tokyo 143-8451
TEL	03(3762)4151
Homepage URL	http://jplsg.jp/
Email	taccn@fb3.so-net.ne.jp

Sponsor
Institute	Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Institute
Department

Funding Source
Organization	Grant for clinical cancer research from the Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)	Grant from the National Center for Child Health and Development

IRB Contact (For public release)
Organization	Ethics Committee, Toho University Omori Medical Center
Address	6-11-1 Omorinishi, Ota-ku, Tokyo 143-8451
Tel	03(3762)4151
Email	omori.rinri@ext.toho-u.ac.jp

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	2014 Year 10 Month 06 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	32
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	2014 Year 09 Month 30 Day
Date of IRB	2014 Year 11 Month 14 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date	2021 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 10 Month 06 Day
Last modified on	2022 Year 04 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017854