UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000515 |
|---|---|
| Receipt number | 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 15:18:16 |
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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
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
Sponsor or person
Institute
Research Grant on Human Genome, Tissue Engineering from the Japanese Ministry of Health, Labor & Welfare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000623
