UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008117 |
|---|---|
| Receipt number | R000009554 |
| Scientific Title | Allogeneic stem cell transplantation from HLA completely mismatched family donor for posttransplant relapse |
| Date of disclosure of the study information | 2012/06/07 |
| Last modified on | 2016/08/26 18:59:55 |
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Basic information
Public title
Allogeneic stem cell transplantation from HLA completely mismatched family donor for posttransplant relapse
Acronym
HLA comlpetely mismatched HSCT
Scientific Title
Allogeneic stem cell transplantation from HLA completely mismatched family donor for posttransplant relapse
Scientific Title:Acronym
HLA comlpetely mismatched HSCT
Region
| Japan |
Condition
Condition
hematologic malignancies relapesd after allogeneic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
to evaluate the safety and efficacy of stem cell transplantation from HLA fully mismatched family donor for hematologic malignancies relapsed after allogeneic transplantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Rate of donor cell engraftment (>90% of donor origin) on day 35
Key secondary outcomes
a) Incidence and severity of chronic GVHD
b) transplantion-associated complications, especially TMA
c) relapse rate
within three months
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
HSCT from HLA fully mismatched family 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
cases with hematologic malignancies relapsed after allogeneic stem cell transplantation who fulfill the following (patient and spousal donor),
[patient]
1) Written informed consent
2) no expectancy of cure with standard therapies including DLI
[family donor]
1) healthy family member who desires to become the donor
2) no available or suitable donor in unrelate bank, cord blood bank, haploidentical relatives (confirmed by our conference)
3) If there is an aveilable spousal donor, the patient and the family can participate either in this protocol or in spousal transplantation protocol (spousal hematopoietic stem cell transplantation for posttransplant relapse UMIN000004132).
Key exclusion criteria
1) Cre > 2.0 mg/dl
2) EF < 40%
3) T-Bil > 2.0 mg/dl
4) AST and/or ALT > 200 U/L
5) SpO2 < 90% (room air)
6) PS (ECOG score) 3-4
Patients with these data due to original diseases are not excluded.
Target sample size
20
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
+81-798-45-6886
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
兵庫医科大学 血液内科
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 07 | 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
| 2012 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 07 | Day |
Last modified on
| 2016 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009554
