UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005138 |
|---|---|
| Receipt number | R000006104 |
| Scientific Title | Donor NK cell infusion for patients after allogeneic hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2011/02/25 |
| Last modified on | 2013/08/30 18:41:25 |
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Basic information
Public title
Donor NK cell infusion for patients after allogeneic hematopoietic stem cell transplantation
Acronym
Donor NK cell infusion for patients after allogeneic hematopoietic stem cell transplantation
Scientific Title
Donor NK cell infusion for patients after allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym
Donor NK cell infusion for patients after allogeneic hematopoietic stem cell transplantation
Region
| Japan |
Condition
Condition
acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, chronic myelogenous leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objectives are to observe incidence of adverse events and graft-versus-host disease and to evaluate anti-tumor effect of donor NK cell infusion performed for molecular relapse after allogeneic hematopoietic stem cell transplantation as phase I/II study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Incidence of adverse events(grater than or equal to CTCAE grade 3), graft-versus-host disease(grater than or equal to grade 1) and anti-tumor effect
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Donor NK cell infusion
NK cell dose is limited by the number of contaminated T cells.
Available to infusion repetitively after 2 weeks interval.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient has molecular relapsed disease.
The patient has no other effective treatments.
Informed consent is obtained.
Key exclusion criteria
The performance status is grater or equal to grade 2 (ECOG standard).
The patient is on graft-versus-host disease.
The patient has severe damages on heart, lung, kidney and liver.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Ogawa |
Organization
Hyogo College of Medicine
Division name
Hematology
Zip code
Address
1-1 Mukogawa-cho Nisinomiya-shi Hyogo-pref.
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
Hematology
Zip code
Address
1-1 Mukogawa-cho Nisinomiya-shi Hyogo-pref.
TEL
0798-45-6886
Homepage URL
kame@hyo-med.ac.jp
Sponsor or person
Institute
Hematology, 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
兵庫医科大学病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 25 | 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
| 2010 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | 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
| 2011 | Year | 02 | Month | 25 | Day |
Last modified on
| 2013 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006104
