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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000015179
Receipt No. R000017622
Scientific Title The efficacy of intravenous immunoglobulin(IVIG) for the maintenance phase of treatment for children with acute lymphoblastic leukemia(ALL)
Date of disclosure of the study information 2014/09/16
Last modified on 2015/05/20

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Basic information
Public title The efficacy of intravenous immunoglobulin(IVIG) for the maintenance
phase of treatment for children with acute lymphoblastic leukemia(ALL)
Acronym The efficacy of intravenous immunoglobulin(IVIG) for the maintenance
phase of treatment for children with acute lymphoblastic leukemia(ALL)
Scientific Title The efficacy of intravenous immunoglobulin(IVIG) for the maintenance
phase of treatment for children with acute lymphoblastic leukemia(ALL)
Scientific Title:Acronym The efficacy of intravenous immunoglobulin(IVIG) for the maintenance
phase of treatment for children with acute lymphoblastic leukemia(ALL)
Region
Japan

Condition
Condition Acute lymphoblastic leukemia
Classification by specialty
Child
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the efficacy and safety of ntravenous immunoglobulin(IVIG) for the maintenance
phase of treatment for children with acute lymphoblastic leukemia(ALL).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of infection.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 administration of immunoglobulin
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 Patients with acute lymphoblastic leukemia
Key exclusion criteria none
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Muramatsu
Organization Nagoya University Graduate School of Medicine
Division name Department of pediatrics,
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8650, Japan
TEL 052-744-2294
Email hideki-muramatsu@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Narita
Organization Nagoya University Graduate School of Medicine
Division name Department of pediatrics,
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8650, Japan
TEL 052-744-2294
Homepage URL
Email stanza-la-speranza@nifty.com

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization a research grant
Organization
Division
Category of Funding Organization Self funding
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
2014 Year 09 Month 16 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 Terminated
Date of protocol fixation
2014 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 09 Month 16 Day
Last modified on
2015 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017622

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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