UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014472 |
|---|---|
| Receipt number | R000016837 |
| Scientific Title | Safety of GVHD prophylaxis in Haploidentical hematopoietic stem cell transplantation with posttransplant cyclophosphamide in combination with thymoglobulin |
| Date of disclosure of the study information | 2014/07/04 |
| Last modified on | 2014/07/03 19:15:33 |
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Basic information
Public title
Safety of GVHD prophylaxis in Haploidentical hematopoietic stem cell transplantation with posttransplant cyclophosphamide in combination with thymoglobulin
Acronym
Safety of GVHD prophylaxis in Haploidentical hematopoietic stem cell transplantation
Scientific Title
Safety of GVHD prophylaxis in Haploidentical hematopoietic stem cell transplantation with posttransplant cyclophosphamide in combination with thymoglobulin
Scientific Title:Acronym
Safety of GVHD prophylaxis in Haploidentical hematopoietic stem cell transplantation
Region
| Japan |
Condition
Condition
Hematopoietic malignancy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety of GVHD prophylaxis in Haploidentical hematopoietic stem cell transplantation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Engraftment and survival without grade III-IV acute GVHD at day60
Key secondary outcomes
1.1 year progression-free survival and overall survival
2.1 year non relapse mortarity
3.primary graft failure
4.secondary graft failure
5.acute and chronic GVHD
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 |
Interventions/Control_1
Conditioning regimen and 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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patient with chemorefractory hematological malignancy, no HLA matched donner but HLA haploidentical donner
Key exclusion criteria
Cases with a sufficient amount (2.0x106/kg CD34-positive cells) could not be harvested peripheral blood hematopoietic stem cells from donor
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kohno |
Organization
Oita University Faculity of Medicine
Division name
Department of Oncology and Hematology
Zip code
Address
1-1 Idaigaoka, Hasama, Yuhu-city, Oita, Japan
TEL
097-549-4411
kkohno@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kohno |
Organization
Oita University Faculity of Medicine
Division name
Department of Oncology and Hematology
Zip code
Address
1-1 Idaigaoka, Hasama, Yuhu-city, Oita, Japan
TEL
097-549-4411
Homepage URL
kkohno@oita-u.ac.jp
Sponsor or person
Institute
Department of Oncology and Hematology, Oita University Faculity of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Oncology and Hematology, Oita University Faculity of Medicine
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
大分大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 03 | Day |
Last modified on
| 2014 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016837
