UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011985 |
|---|---|
| Receipt number | R000013069 |
| Scientific Title | HLA 2-3 antigen-mismatched stem cell transplantation for refracotry hematologic malignancies |
| Date of disclosure of the study information | 2013/10/10 |
| Last modified on | 2025/04/16 17:21:35 |
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Basic information
Public title
HLA 2-3 antigen-mismatched stem cell transplantation for refracotry hematologic malignancies
Acronym
Haploidentical stem cell transplantation for hematologic malignancies
Scientific Title
HLA 2-3 antigen-mismatched stem cell transplantation for refracotry hematologic malignancies
Scientific Title:Acronym
Haploidentical stem cell transplantation for hematologic malignancies
Region
| Japan |
Condition
Condition
refractory hematologic malignancies
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and efficacy of HLA haploidentical stem cell trnasplantation for refractory hematologic malignancies
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival rate at 100 days after transplantation
Key secondary outcomes
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
fludarabine 30mg/m2 day -11,-10,-9,-8,-7,-6
melphalan 70mg/m2 day -7,-6
(cytarabine 2g/m2 day -11,-10,-9,-8)
TBI 3Gy day -5
ATG 0.5mg/kg day -3
ATG 1mg/kg day -2,-1
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Relapse after allogeneic transplantation
2) Lack an avavilable HLA identical or 1 antigen-mismatched related or unrelated donor
Key exclusion criteria
1) With uncontrol diabetes
2) With uncontrol hypertension
3) With active cancer
4) Positive of HBs Ag or HBe Ag
5) Positive of HIV Ab
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Yano |
Organization
Jikei University Hospital
Division name
Clinical Oncology and Hematology
Zip code
105-8461
Address
3-25-8 Nishi Shinbashi Minatoku Tokyo Japan
TEL
03-3433-1111
yano@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Yano |
Organization
Jikei Universtiy Hospital
Division name
Clinical Oncology and Hematology
Zip code
105-8461
Address
3-25-8 Nishi Shinbashi Minatoku Tokyo Japan
TEL
03-3433-1111
Homepage URL
yano@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jikei University School of Medicne
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
Jikei University Ethics Committee
Address
3-25-8 Nishi-Shinbashi Minato-ku
Tel
03-3433-1111
rinri@jikei.ac.jp
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
| 2013 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.dropbox.com/scl/fi/v4v5997gd6furmu3lnzpo/HLA-_230309.doc?rlkey=opib48xj9mkhp9pwafemhldnt
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
28
Results
All cases were confirmed to be viable. All patients with non-CR disease at transplant relapsed.
Results date posted
| 2025 | Year | 04 | Month | 16 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Currently analyzing results
Date of the first journal publication of results
Baseline Characteristics
hematological malignancies
Participant flow
Allogeneic transplantation performed on a patient undergoing treatment in our department.
Adverse events
Infection and GVHD were observed, but no treatment-related deaths were observed.
Outcome measures
Survival rate at 100 days after transplantation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 07 | Day |
Last modified on
| 2025 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013069
