UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000317 |
|---|---|
| Receipt number | 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 12:04:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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/
jplsgdata@nnh.hosp.go.jp
Sponsor or person
Institute
Japanese Pediatric Leukemia/Lymphoma Studu 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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000397
