UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018426 |
|---|---|
| Receipt number | R000021332 |
| Scientific Title | The study of the efficacy of late intensification therapy and biochemical markers for pediatric Langerhans cell histiocytosis (JLSG-02) |
| Date of disclosure of the study information | 2015/07/26 |
| Last modified on | 2016/06/07 17:22:12 |
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Basic information
Public title
The study of the efficacy of late intensification therapy and biochemical markers for pediatric Langerhans cell histiocytosis (JLSG-02)
Acronym
JLSG-02
Scientific Title
The study of the efficacy of late intensification therapy and biochemical markers for pediatric Langerhans cell histiocytosis (JLSG-02)
Scientific Title:Acronym
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.
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
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
| 1st name | |
| Middle name | |
| Last name | Akira Morimoto |
Organization
Jichi Medical University
Division name
Pediatrics
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
0285-44-2111
akira@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Morimoto |
Organization
Jichi Medical University
Division name
Pediatrics
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
0285-44-2111
Homepage URL
http://www.jlsg.jp/
info@jlsg.jp
Sponsor or person
Institute
Japan LCH Study Group
Institute
Department
Personal name
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)
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
| 2015 | Year | 07 | Month | 26 | Day |
Related information
URL releasing protocol
http://www.jlsg.jp/english/JLSG-02protocol2.html
Publication of results
Published
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
| 2001 | Year | 12 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021332
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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