UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001758
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute RICBT Study Group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002115

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.