UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000403 |
|---|---|
| Receipt number | R000000492 |
| Scientific Title | HLA2-3 antigen mismatched stem cell transplantation from related donor |
| Date of disclosure of the study information | 2006/04/12 |
| Last modified on | 2017/04/19 09:33:34 |
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Basic information
Public title
HLA2-3 antigen mismatched stem cell transplantation from related donor
Acronym
HLA2-3 antigen mismatched stem cell transplantation from related donor
Scientific Title
HLA2-3 antigen mismatched stem cell transplantation from related donor
Scientific Title:Acronym
HLA2-3 antigen mismatched stem cell transplantation from related donor
Region
| Japan |
Condition
Condition
Refractory hematologic malignancies (acute myeloid leukemia, chronic myeloid leukemia, myelodysplastic syndrome, malignant lymphoma, multiple myeloma, severe aplastic anemia)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the safety and efficacy of HLA 2-3 antigen mismatched stem cell transplantation from related donor for refractory hematologic malignancies
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Rate of donor cell engraftment (>90% of donor origin) and incidence of severe GVHD (Phase I)
Disease free survival at 1 year after transplantation (Phase II)
Key secondary outcomes
Incidence and severity of chronic GVHD
Treatment related mortality within 1 year after transplantation
Incidence of infections (bacteria, fungus, virus, etc)
Immune reconstitution after transplantation
GVL effect
Late onset transplantation related complications
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
HLA 2-3 antigen mismatched stem cell transplantation from related donor
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
| 15 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Written informed consent.
2) Unavailability of HLA (A, B, DR)-matched or -one antigen mismatched-related donor.
3) Unavailability of HLA (A, B, DR)-matched or one allele of HLA-DRB1 mismatched-unrelated donor or needs urgent transplantation.
4) Availability of HLA 2-3 antigen mismatched related donor.
5) In case of hematologic malignancy in an advanced stage, patients could choose an HLA 2-3 antigen-mismatched donor, even if they have an HLA-matched or -1 antigen-mismatched donor.
6) Sufficient organ function
6-1) Ejection Fraction >= 50%
6-2) serum total billirubin is needed to be less than 2.5 times the normal upper limit
6-3) serum creatinine level <= 1.5* upper limit of institution
Key exclusion criteria
1) Allergy for the agents used in conditioning or GVHD prophylaxis
2) Patients who are considered as inappropriate with other reasons
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Ogawa |
Organization
Hyogo College of Medicine
Division name
Division of Hematology, Department of Internal Medicine
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya city, Hyogo
TEL
0798-45-6886
haplo@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Ikegame |
Organization
Hyogo College of Medicine
Division name
Division of Hematology, Department of Internal Medicine
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya city, Hyogo
TEL
0798-45-6886
Homepage URL
kame@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
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
| 2006 | Year | 04 | 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
| 2006 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | 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
| 2006 | Year | 04 | Month | 11 | Day |
Last modified on
| 2017 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000492
