UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003555 |
|---|---|
| Receipt number | R000004312 |
| Scientific Title | Intra-bone marrow-bone marrow transplantation (IBM-BMT) with perfusion method |
| Date of disclosure of the study information | 2010/05/01 |
| Last modified on | 2010/12/01 17:30:45 |
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Basic information
Public title
Intra-bone marrow-bone marrow transplantation (IBM-BMT) with perfusion method
Acronym
Intra-bone marrow-bone marrow transplantation (IBM-BMT)
Scientific Title
Intra-bone marrow-bone marrow transplantation (IBM-BMT) with perfusion method
Scientific Title:Acronym
Intra-bone marrow-bone marrow transplantation (IBM-BMT)
Region
| Japan |
Condition
Condition
Refractory hematological malignancies
(acute leukemia, chronic myeloid leukemia, myelodysplastic syndrome, malignant lymphoma)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate feasibility of IBM-BMT with perfusion method
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Donor: To evaluate feasibility of perfusion method
Recipient: To evaluate feasibility of IBM-BMT with perfusion method
Key secondary outcomes
Donor :operation time, anesthesia time numbers of puncture site, volume of blood transfusion, number of bone marrow nuclear cell, number of CD3,CD34 positive cells, contamination of red blood cells
Recipient: Rate of donor cell engrafment, Incidence and severity of acute and chronic GVHD, Overall survival and disease free survival at 1 year after transplantation, Treatment related mortality within 1 year after transplantation, Incidence of infections (bacteria, fungus, virus,etc) Immune reconstitution after transplantation
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
| Maneuver |
Interventions/Control_1
To evaluate feasibility of IBM-BMT with perfusion method
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
| 12 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Written informed consent
2) Availability of HLA-matched or three antigen mismatched-related donor.
3) Performance status :0 or 1(ECOG)
4) Sufficient organ function
Serum total billirubin is needed to be less than 2.0mg/dl
Serum creatinine level is needed to be less than 2.0mg/dl
PaO2>=60mmHg or SaO2>=90%(room air)
Normal ECG and Ejection fraction >=50%
5) Patients who are considered as appropriate after examination
Key exclusion criteria
Positivity of HBs Ag, HIV Ab
(not exclusion of HCV Ab positive)
Patient with active infection
Bone marrow show fibrosis
Patients who are considered as inappropriate with other reasons
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shosaku Nomura |
Organization
Kansai Medical University Hirakata Hospital
Division name
The Department of Hemato-oncology
Zip code
Address
2-3-1,Shinmachi,Hirakata-city,Osaka
TEL
072-804-2831
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Mori |
Organization
Kansai Medical University Hirakata Hospital
Division name
The Department of Hemato-oncology
Zip code
Address
2-3-1,Shinmachi,Hirakata-city,Osaka
TEL
072-804-2831
Homepage URL
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Fund of MHLW
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hyogo Medical College Dept. of Hematology
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
| 2010 | Year | 05 | Month | 01 | 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
Suspended
Date of protocol fixation
| 2010 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | 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
| 2010 | Year | 05 | Month | 01 | Day |
Last modified on
| 2010 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004312
