UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of the efficacy of late intensification therapy and biochemical markers for pediatric Langerhans cell histiocytosis (JLSG-02)
Title of the study (Brief title)	JLSG-02
Region	Japan

Condition
Condition	Langerhans cell histiocytosis
Classification by specialty	Pediatrics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	(a) To improve event-free survival (EFS) by intensifying the induction therapy regimen through increasing the PSL dose and prolonging maintenance therapy, thereby extending the total treatment duration to 54 weeks; (b) to improve survival of MS patients with progressive disease by adding CSA to the salvage regimen; and (c) to find out biochemical markers to reflect disease activity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Event free survival at 5 years.
Key secondary outcomes	Overall survival at 5 years.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Multiple bone and Multi-system type: Induction A (6 weeks)Patients who had response to Induction A (GR / PR): Early maintenance A (24 weeks) and Late maintenance C (24 weeks) Multiple bone and Multi-system type: Induction A (6 weeks)Patients who had no response to Induction A (NR): Induction B1 (6 weeks), Early maintenance B (24 weeks) and Late maintenance C (24 weeks) Multiple bone and Multi-system type: Induction A (6 weeks)Patients who had no response to Induction A (PD): Induction B2 (6 weeks), Early maintenance B (24 weeks) and Late maintenance C (24 weeks)
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	0 years-old <=
Age-upper limit	18 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients with histologicaly diagnosed LCH 2. Patients with Multiple bone or Multi-system type LCH
Key exclusion criteria	1. Patients with organ failure which make difficult to carry out the treatment 2. Patients receiving other treatment except steroids or surgical treatment for LCH 3. Informed consent is not obtained from patients and / or the guardians for treatment JLSG-02
Target sample size	150

Research contact person
Name of lead principal investigator	Akira Morimoto
Organization	Jichi Medical University
Division name	Pediatrics
Address	3311-1 Yakushiji, Shimotsuke, Tochigi
TEL	0285-44-2111
Email	akira@jichi.ac.jp

Public contact
Name of contact person	Akira Morimoto
Organization	Jichi Medical University
Division name	Pediatrics
Address	3311-1 Yakushiji, Shimotsuke, Tochigi
TEL	0285-44-2111
Homepage URL	http://www.jlsg.jp/
Email	info@jlsg.jp

Sponsor
Institute	Japan LCH Study Group
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	2015 Year 07 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2001 Year 12 Month 01 Day
Anticipated trial start date	2002 Year 01 Month 01 Day
Last follow-up date	2013 Year 12 Month 31 Day
Date of closure to data entry	2014 Year 03 Month 31 Day
Date trial data considered complete	2014 Year 09 Month 30 Day
Date analysis concluded	2015 Year 01 Month 31 Day

Related information
URL releasing protocol	http://www.jlsg.jp/english/JLSG-02protocol2.html
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 26 Day
Last modified on	2016 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021332