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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000515
Receipt No. R000000623
Scientific Title Study for the establishment of conditioning regimen in cord blood transplantation for children: To evaluate feasibility and effectiveness of cord blood transplantation using the conditioning regimen including Fludarabine phosphate for children with acute leukemia
Date of disclosure of the study information 2006/11/10
Last modified on 2011/04/20

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Basic information
Public title Study for the establishment of conditioning regimen in cord blood transplantation for children:
To evaluate feasibility and effectiveness of cord blood transplantation using the conditioning regimen including Fludarabine phosphate for children with acute leukemia
Acronym Clinical study to evaluate feasibility and effeteness of conditioning regimen using Fludarabine phosphate (C-SHOT-0602)
Scientific Title Study for the establishment of conditioning regimen in cord blood transplantation for children:
To evaluate feasibility and effectiveness of cord blood transplantation using the conditioning regimen including Fludarabine phosphate for children with acute leukemia
Scientific Title:Acronym Clinical study to evaluate feasibility and effeteness of conditioning regimen using Fludarabine phosphate (C-SHOT-0602)
Region
Japan

Condition
Condition Acute leukemia
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To establish the optimal preconditioning regimen in the setting of URCBT for pediatric patients with acute leukemia, we perform this trial to evaluate feasibility and effectiveness of unrelated cord blood transplantation (URCBT) using a conditioning regimen with fludarabine phosphate, total body irradiation, and cyclophosphamide
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Hematopoietic engraftment at 100 days after cord blood transplantation
Key secondary outcomes Over all survival at 1 year after transplant,
Event free survival at 1 year after transplant,
Preconditioning-related toxicity,
Incidence and severity of acute and chronic graft versus host disease,
Time of onset of GVHD,
Time interval between transplant and hematological recovery
Chimerism analysis

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 Maneuver
Interventions/Control_1 To study feasibility and effectiveness of cord blood transplantation using the conditioning regimen including Frudarabine phosphate in children with acute leukemia requiring hematopoietic stem cell transplantation
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
16 years-old >
Gender Male and Female
Key inclusion criteria 1)Children with acute leukemia requiring unrelated cord blood transplantation because of the lack of a suitable donor.
2)Patient who receives CBT as the first haematopoietic stem cell transplantation
3)Age:equal or older than 6 month old, younger than 16 years old
4)Children who has cord blood unit with a cell dose of equal or more than 2x107/kg and HLA 2=>antigens mismatches
5)Children without hypersensitivity to drugs given for conditioning and GVHD prophylaxis.
6)The written informed consent is available.
Key exclusion criteria 1)Intracranial hemorrhage
2)ECOG's performance status;2 or more
3)Children with cardiovascular diseases requiring treatment
4)Children with respiratory dysfunction requiring oxygen
5)Serum creatinine>3 x age adjusted normal value
6)Total bilirubin>2 x age adjusted normal value
7)Down's syndrome or Fragile chromosome syndrome
8)Children with uncontrollable infection
9)History of organ transplantation
10)Children registered to other clinical study for hematopoietic cell transplantation
11)Physician's decision that it is not appropriate to register the patient to this study for other reasons.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name 1) Shun-ichi Kato, 2) Keiichi Isoyama
Organization 1) Tokai University, School of Medicine
2) Showa University Fujigaoka Hospital
Division name 1) Research Center for regenerative medicine ,2) Department of Pediatrics
Zip code
Address 1) Boseidai, Isehara-city, Kanagawa,2)1-30 Fujigaoka Aoba-ku Yokohama
TEL 0463-93-1121
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shiro Yoshiba
Organization Registry office of cord blood transplantation in children
Division name 2) Research Center for regenerative medicine, Tokai University, School of Medicine
Zip code
Address Boseidai, Isehara-city, Kanagawa
TEL 0463-93-1121
Homepage URL
Email

Sponsor
Institute Research Grant on Human Genome, Tissue Engineering from the Japanese Ministry of Health, Labor & Welfare
Institute
Department

Funding Source
Organization Research Grant on Human Genome, Tissue Engineering from the Japanese Ministry of Health, Labor & 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 11 Month 10 Day

Related information
URL releasing protocol http://www.c-shot.or.jp/study/
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
2006 Year 09 Month 06 Day
Date of IRB
Anticipated trial start date
2006 Year 11 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 09 Month 01 Day
Date trial data considered complete
2010 Year 03 Month 01 Day
Date analysis concluded
2010 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 11 Month 06 Day
Last modified on
2011 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000623

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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