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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002212
Receipt No. 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

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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
Email 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/
Email s-sunami@sc4.so-net.ne.jp

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

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002718

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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