UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014777 |
|---|---|
| Receipt number | R000014489 |
| Scientific Title | Study on safety and efficacy of granulocyte transfusion mobilized with G-CSF in related donor |
| Date of disclosure of the study information | 2014/08/13 |
| Last modified on | 2014/08/06 14:19:03 |
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Basic information
Public title
Study on safety and efficacy of granulocyte transfusion mobilized with G-CSF in related donor
Acronym
Granulocyte transfusion from related donor
Scientific Title
Study on safety and efficacy of granulocyte transfusion mobilized with G-CSF in related donor
Scientific Title:Acronym
Granulocyte transfusion from related donor
Region
| Japan |
Condition
Condition
Severe neutropenic patients following alloHSCT or chemotherapy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate safety in both donor and recipient
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Evaluate safety and efficacy in both donor and recipient
Key secondary outcomes
Overall survival in recipient at 30 days after granulocyte transfusion
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
| Other |
Interventions/Control_1
Granulocyte transfusion
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
| 20 | years-old | <= |
Age-upper limit
| 54 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Recipient: Severe neutropenia, recovery is not expected within five days, severe infection with elevated CRP level or active focus to be fatal infection, written informed consent.
Donor: Relative within fourth degree, 20 to 54 years, compatible ABO blood type or minor incompatible, healthy donor, written informed consent.
Key exclusion criteria
Recipient: not expected to survive more than 30 days, self hematopoiesis is not expected to recover within 30 days.
Donor: allergy aginst G-CSF, pregnant or possible to be pregnant, breast feeding, history of thrombosisi or have risk of thrombosis, splenomegaly, comorbidiy or history of interstitial pneumonia, history of cancer, comorbidities of cardiac, pulmonary, renal diseases to be treated, comorbidities of inflammatory, autoimmune diseases to be treated.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyoshi Ishii |
Organization
Kansai Medical University
Division name
First Department of Internal Medicine
Zip code
Address
2-5-1 Sinamachi, Hirakata, Osaka
TEL
072-804-2503
ishiikaz@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Fujita |
Organization
Kansai Medical University
Division name
First Department of Internal Medicine
Zip code
Address
2-5-1 Sinamachi, Hirakata, Osaka
TEL
072-804-2503
Homepage URL
fujitas@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
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
関西医科大学附属枚方病院（大阪府）
Kansai Medical University Hirakata Hospital (Osaka)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 11 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 05 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 05 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 05 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 06 | Day |
Last modified on
| 2014 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014489
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
