UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002212 |
|---|---|
| Receipt number | R000002718 |
| Scientific Title | Phase II clinical trial of advanced stage ymphoblastic lymphoma. A Japanese Pediatric Cooperative Study |
| Date of disclosure of the study information | 2009/07/26 |
| Last modified on | 2014/02/24 14:19:13 |
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Basic information
Public title
Phase II clinical trial of advanced stage ymphoblastic lymphoma. A Japanese Pediatric Cooperative Study
Acronym
Clinical trial of advanced stage childhood lymphoblastic lymphoma
Scientific Title
Phase II clinical trial of advanced stage ymphoblastic lymphoma. A Japanese Pediatric Cooperative Study
Scientific Title:Acronym
Clinical trial of advanced stage childhood lymphoblastic lymphoma
Region
| Japan |
Condition
Condition
Advanced stage lymphoblastic lymphoma of children.
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish the standard therapy in children with advanced stage lymphoblastic lymphoma.To evaluate the efficacy and safety of BFM type chemotherapy in children with advanced stage lymphoblastic lymphoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
3 year event-free survival
Key secondary outcomes
(1) 3year overall survival
(2)Incidence of therapy-rerated severe toxicity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment regimen has fundamentally BFM backbone and intensified with pulse type early and late maintenance phase, which consisted with MTX, VCR, L-ASP, PSL, 6MP, and CPA.
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
Newly diagnosed patients with advanced stage T and B cell lymphoblastic lymphoma
Key exclusion criteria
1, Down's syndrome
2, previous malignancy of any type
3, Prior stem cell or organ transplantation
4, Congenital or acquired immunodeficiency
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shosuke Sunami |
Organization
Japanese Red Cross Narita Hospital
Division name
Department of Pediatrics
Zip code
Address
90-1 Iidacho Narita city Japan
TEL
0476222311
s-sunami@sc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shosuke Sunami |
Organization
Japanese Red Cross Narita Hospital
Division name
Department of Pediatrics
Zip code
Address
90-1 Iidacho Narita city Japan
TEL
0476222311
Homepage URL
http://www.jplsg.jp:80/
s-sunami@sc4.so-net.ne.jp
Sponsor or person
Institute
Japanese Pediatric Leukemia/Lymphoma Study Group(JPLSG)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
| 2009 | Year | 07 | Month | 26 | 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
| 2004 | Year | 10 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 16 | Day |
Last modified on
| 2014 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002718
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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