UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001758 |
|---|---|
| Receipt number | R000002115 |
| Scientific Title | The efficacy of cyclospolin A and low dose mycophenolate mofetil to prevent GVHD for reduced-intensity (fludarabine , cyclophosphamide , total body irradiation) cord blood stem cell transplantation |
| Date of disclosure of the study information | 2009/03/06 |
| Last modified on | 2009/03/05 19:57:12 |
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Basic information
Public title
The efficacy of cyclospolin A and low dose mycophenolate mofetil to prevent GVHD for reduced-intensity (fludarabine , cyclophosphamide , total body irradiation) cord blood stem cell transplantation
Acronym
The efficacy of cyclospolin A and low dose mycophenolate mofetil to prevent GVHD for reduced-intensity(FLU,CY,TBI) cord blood stem cell transplantation
Scientific Title
The efficacy of cyclospolin A and low dose mycophenolate mofetil to prevent GVHD for reduced-intensity (fludarabine , cyclophosphamide , total body irradiation) cord blood stem cell transplantation
Scientific Title:Acronym
The efficacy of cyclospolin A and low dose mycophenolate mofetil to prevent GVHD for reduced-intensity(FLU,CY,TBI) cord blood stem cell transplantation
Region
| Japan |
Condition
Condition
Hematologic malignancies
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The safety and efficacy of cyclospolin A and mycophenolate mofetil to prevent GVHD for reduced-intensity ( FLU , CY , TBI ) cord blood stem cell transplantation .
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Non relapse mortality on day 100 post transplantaion
Key secondary outcomes
1)Incidence and severity of acute GVHD
2)Incidence of hepatic veno-occlusive disease and thrombotic microangiopathy
3)Incidence of infectious disease
4)Disease-free survival and overall survival rate at 1 year and 2 years after transplantation
5)Engraftment rate 100 days after transplantation
6)Time to hematopoietic recovery
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
Intravenous injection of fludarabine (30mg/m2/day, for 6 days) and cyclophosphamide (50mg/kg/day,once)
Use cyclospolin A and mycophenolate mofetil ( for 30 days) as a GVHD prophylaxis
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosis as hematological malignancy
2) Unavailability of HLA matched- related or unrelated donor , or needs urgent transplantation.
3) Availability of CB uint
4)As inappropriate requirements for myeloablative conditioning, satisfy one of the following criteria.
a) Aged over 50 years
b)Impaired organ function
c)Previous stem cell transplantation (except re-transplantaion with CB unit ,but the entry is once.)
5) Written informed consent
Key exclusion criteria
1) Double cancer
2) Sever mental disease
3)Seropositive to HIV
4) History of adverse reaction for the agents included in the protocol in conditioning (fludarabine, cyclophosphamide), in GVHD prophylaxis (Cyclosporine A, mycophenolate mofetil)
5) Pregnant or lactating women
6)Inadequate to entry judged by investigators.
Target sample size
57
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Kodo |
Organization
Tokyo Cord Blood Bank
Division name
Tokyo Cord Blood Bank
Zip code
Address
1-16-19,Higashi-Yotugi,Katsushika-Ku,Tokyo,Japan
TEL
03-5671-3510
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Kodo |
Organization
Tokyo Cord Blood Bank
Division name
Tokyo Cord Blood Bank
Zip code
Address
1-16-19,Higashi-Yotugi,Katsushika-Ku,Tokyo,Japan
TEL
03-5671-3510
Homepage URL
Sponsor or person
Institute
RICBT Study Group
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2009 | Year | 03 | Month | 06 | 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
Date of protocol fixation
| 2008 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | 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
| 2009 | Year | 03 | Month | 05 | Day |
Last modified on
| 2009 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002115
