UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009517 |
|---|---|
| Receipt number | R000011181 |
| Scientific Title | Clonal deletion of T lymphocytes against host organ by early post-transplant cyclophosphamide: clinical study of GVHD prophylaxis in HLA-haploidentical bone marrow transplantation |
| Date of disclosure of the study information | 2012/12/12 |
| Last modified on | 2014/06/11 16:20:12 |
* 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
Clonal deletion of T lymphocytes against host organ by early post-transplant cyclophosphamide: clinical study of GVHD prophylaxis in HLA-haploidentical bone marrow transplantation
Acronym
HLA-haploidentical BMT using post-transplant CY
Scientific Title
Clonal deletion of T lymphocytes against host organ by early post-transplant cyclophosphamide: clinical study of GVHD prophylaxis in HLA-haploidentical bone marrow transplantation
Scientific Title:Acronym
HLA-haploidentical BMT using post-transplant CY
Region
| Japan |
Condition
Condition
Hematological malignancies and malignant solid tumors
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether administration of CY at day 3 after BMT prevents acute GVHD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate and severity of acute GVHD.
Key secondary outcomes
Engraftment, adverse events, relapse rate, event-free survival. (Monitoring of chronic GVHD)
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Administration of CY at day 3 after BMT.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Macro/micro residual disease after conventional treatment. Or, relapse after allogeneic HSCT. 2. Written consent was obtained.
Key exclusion criteria
1. Having a severe complication (NCI-CTCAE ver3.0 Grade II or more). 2. Having an uncontrolled infection. 3. Physician's decision.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihisa SAWADA |
Organization
Osaka medical center and research institute for maternal and child health
Division name
Hematology/Oncology
Zip code
Address
840 Murodo, Izumi City, Osaka 594-1101, Japan
TEL
0725-56-1220
asawada@mch.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihisa SAWADA |
Organization
Osaka medical center and research institute for maternal and child health
Division name
Hematology/Oncology
Zip code
Address
840 Murodo, Izumi City, Osaka 594-1101, Japan
TEL
0725-56-1220
Homepage URL
asawada@mch.pref.osaka.jp
Sponsor or person
Institute
Osaka medical center and research institute for maternal and child health
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 12 | Month | 12 | 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
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 11 | Day |
Last modified on
| 2014 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011181
