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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000675
Receipt No. 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

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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
Email

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
Email akikuchi-tky@umin.ac.jp

Sponsor
Institute Japan Pediatric Leukemia/Lymphoma Study Group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000811

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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