UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008067 |
|---|---|
| Receipt number | R000009282 |
| Scientific Title | Risk Stratified Clinical Research on Children and Young Adult with Newly Diagnosed Langerhans cell Histiocytosis |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2022/05/23 17:07:47 |
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Basic information
Public title
Risk Stratified Clinical Research on Children and Young Adult with Newly Diagnosed Langerhans cell Histiocytosis
Acronym
LCH-12
Scientific Title
Risk Stratified Clinical Research on Children and Young Adult with Newly Diagnosed Langerhans cell Histiocytosis
Scientific Title:Acronym
LCH-12
Region
| Japan |
Condition
Condition
Langerhans cell histiocytosis
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of treatment intensified by vinca alkaloid on children and young adult less than 20 years old with newly diagnosed multi-system and multiple bone type Langerhans cell histiocytosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Event-free survival rates in different type of disease.
Key secondary outcomes
Incidence of an adverse event.
Overall survival rates
A response rate of remission induction phase.
The validity of the LCH disease clinical score.
The incidence of irreversible lesions.
Event-free survival rates in all registered cases, including the clinical trials excluded patients.
Overall survival rates in all registered cases, including the clinical trials excluded patients.
Incidence of irreversible lesions in all registered cases, including the clinical trials excluded patients.
Analysis of humoral factors to reflect the disease activity and prognosis of LCH in all registered cases, including the clinical trials excluded patients.
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 type: Induction A (6 weeks) and Early maintenance A (24 weeks)
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)
Multi-system type: Induction A (6 weeks)Patients who had no response to Induction A (NR): Induction B (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
| Not applicable |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with histologicaly diagnosed LCH
2. Patients whose biopsied specimens can be submitted for central diagnosis review within two weeks from registration to the clinical study
Key exclusion criteria
1. Patients other than Multiple bone or Multi-system type LCH
2. Patients with organ failure which make difficult to carry out the treatment
3. Patients receiving other treatment except steroids or surgical treatment for LCH
4. Patients with neurodegenerative LCH
5. Patients with any severe bleeding in CNS system
6. Patients with an uncontrolled systemic infection
7. Pregnant women
8. Lactating women
9. Patients whose body weight is less than 2500g
10. Patients with history or concurrent malignancy
11. Patients with a congenital or acquired immunodeficiency syndrome.
12. Informed consent is not obtained from patients and / or the guardians for treatment LCH-12
13. Age is greater than or equal to 20 years old at the start of treatment
14. When the doctor determines that the other inappropriate
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Morimoto |
Organization
Jichi Medical University
Division name
Pediatrics
Zip code
3290498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7366
akira@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Morimoto |
Organization
Jichi Medical University
Division name
Department of Pediatrics, Children's Medical center Tochigi
Zip code
3290498
Address
3311-1Yakushiji, Shimotsuke, Tochigi, 329-0498
TEL
0285-58-7366
Homepage URL
akira@jichi.ac.jp
Sponsor or person
Institute
Japanese Peditric Leukemia/Lymphoma Study Group(JPLSG)
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Section of Research Support, Jichi Medical University
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
Tel
0285442111
shien@jichi.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
| 2012 | Year | 06 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2012 | Year | 05 | Month | 31 | Day |
Last modified on
| 2022 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009282
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
