UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000675 |
|---|---|
| Receipt number | R000000811 |
| Scientific Title | randomized trial for the efficacy of primary prophylaxis with granulocyte colony stimulating factor in advanced childhood mature B-cell malignancies |
| Date of disclosure of the study information | 2007/04/11 |
| Last modified on | 2011/10/11 09:43:54 |
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Basic information
Public title
randomized trial for the efficacy of primary prophylaxis with granulocyte colony stimulating factor in advanced childhood mature B-cell malignancies
Acronym
B-NHL03 G-CSF
Scientific Title
randomized trial for the efficacy of primary prophylaxis with granulocyte colony stimulating factor in advanced childhood mature B-cell malignancies
Scientific Title:Acronym
B-NHL03 G-CSF
Region
| Japan |
Condition
Condition
advanced childhood mature B-cell malignancies
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of primary prophylaxis with granulocyte colony stimulating factor (G-CSF; lenograstim) in advanced childhood mature B-cell malignancies
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of febrile neutropenia
Key secondary outcomes
Incidence of severe infection
duration of neutropenia
febrile period
treatment period
Incidence of Grade 3,4 adverse event in stomatitis,thrombocytopenia,interstitial pneumonitis,acute respiratory distress syndrome, myalgia and bone pain
transfusion number of red blood cell and platelet
remission induction rate
event free survival at 1 year and 2 years
total medical costs in treatment period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
granulocyte colony stimulating factor
Interventions/Control_2
no granulocyte colony stimulating factor
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
regiatered cases in Group3,4 of JPLSG multicenter trial for childhood mature B-cell malignancies
informed consent from the patients' guardians
Key exclusion criteria
severe dysfunction in liver, kidney, heart and lung
uncontrolable complications such as severe infection, diabetes mellitua or myocardial infarction
hypersensitivity for lenograstim or other G-CSF products
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Kikuchi |
Organization
Teikyo University School of Medicine
Division name
Department of Pediatrics
Zip code
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan
TEL
03-3964-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Kikuchi |
Organization
Teikyo University School of Medicine
Division name
Department of Pediatrics
Zip code
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan
TEL
03-3964-1211
Homepage URL
akikuchi-tky@umin.ac.jp
Sponsor or person
Institute
Japan Pediatric Leukemia/Lymphoma Study Group
Institute
Department
Personal name
Funding Source
Organization
Japan Pediatric Leukemia/Lymphoma Study Group
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
| 2007 | Year | 04 | Month | 11 | 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 | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 10 | 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
| 2007 | Year | 04 | Month | 10 | Day |
Last modified on
| 2011 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000811
