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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000317
Receipt No. R000000397
Scientific Title Phase II clinical trials of mature B-cell neoplasms in children: A Japanese Cooperative Studies
Date of disclosure of the study information 2006/02/05
Last modified on 2014/09/01

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Basic information
Public title Phase II clinical trials of mature B-cell neoplasms in children: A Japanese Cooperative Studies
Acronym Clinical trials of childhood B-cell lymphomas
Scientific Title Phase II clinical trials of mature B-cell neoplasms in children: A Japanese Cooperative Studies
Scientific Title:Acronym Clinical trials of childhood B-cell lymphomas
Region
Japan

Condition
Condition mature B-cell non-Hodgkin's lymphoa
Classification by specialty
Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish the standard therapy in children with mature B-cell non-Hodgkin's lymphoa. To evaluate the efficacy and safety of short-duration, intensive chemotherapy in children with mature B-cell non-Hodgkin's lymphoa
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 2 year event-free survival
Key secondary outcomes (1) 2 year overall survival
(2) incidence of therapy-related 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 All registered patients are stratified into four risk groups(G1:stage I/II and resected tumors;G2:stage I/II and unresected tumors;G3:stage III/stage IV CNS negative; G4:stage IV CNS positive & Burkitt leukemia). Patients in G1 will receive two courses of A. Patients in G2 will receive two courses of A and B. Patients in G3 will receive four courses of A and two courses of B. Patients in G4 will receive two courses of A1, A2 and B. Course A consits of PSL,(HD)MTX,CPA, VCR,THP, and course B consists of Ara-C,MTX,VCR,DEX,VP-16. Cranial radiation is omitted for all patients. Standard therapy durations are four weeks in G1, twelve weeks in G2 and eighteen weeks in G3/G4.
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
18 years-old >
Gender Male and Female
Key inclusion criteria Newly diagnosed patients with mature B-cell lymphomas including diffuse large B-cell lymphoma,mediastinal large B-cell lymphoma and Burkitt lymphoma/leukemia.
Key exclusion criteria 1, Down's syndrome(21 trisomy)
2, Previous malignancy of any type
3, Prior stem cell/organ
transplantation
4, Congenital immunodeficiency
5, HIV positivity
Target sample size 308

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahito Tsurusawa
Organization Aichi Medcial University Hospital
Division name Department of Pediatrics
Zip code
Address Nagakute-cho, Aichi 480-1195 Japan
TEL 0561-62-3311
Email mtsuru@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Saito akiko
Organization JPLSG
Division name data center
Zip code
Address 460-0001,Nagoya, naka-ku,sannomaru 4-1-1
TEL 052-951-1111
Homepage URL http://www.jplsg.jp/
Email jplsgdata@nnh.hosp.go.jp

Sponsor
Institute Japanese Pediatric Leukemia/Lymphoma Studu 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
2006 Year 02 Month 05 Day

Related information
URL releasing protocol http://www.jplsg.jp/
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed
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
2004 Year 10 Month 29 Day
Date of IRB
Anticipated trial start date
2005 Year 02 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2013 Year 07 Month 30 Day

Other
Other related information

Management information
Registered date
2006 Year 01 Month 31 Day
Last modified on
2014 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000397

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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