UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006529 |
|---|---|
| Receipt number | R000005984 |
| Scientific Title | Intra-bone marrow injection of cord blood following reduced-intensity conditioning: A phase II study |
| Date of disclosure of the study information | 2011/10/12 |
| Last modified on | 2021/06/29 12:49:21 |
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Basic information
Public title
Intra-bone marrow injection of cord blood following reduced-intensity conditioning: A phase II study
Acronym
Intra-bone marrow injection of cord blood following reduced-intensity conditioning: A phase II study
Scientific Title
Intra-bone marrow injection of cord blood following reduced-intensity conditioning: A phase II study
Scientific Title:Acronym
Intra-bone marrow injection of cord blood following reduced-intensity conditioning: A phase II study
Region
| Japan |
Condition
Condition
Refractory hematologic malignancies (acute myeloid leukemia, chronic myeloid leukemia, myelodysplastic syndrome, malignant lymphoma)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy of Intra-bone marrow injection of cord blood following reduced-intensity conditioning
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Rate of donor cell engraftment (>90% of donor origin)
Key secondary outcomes
Incidence of severe GVHD
Incidence and severity of chronic GVHD
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intra-bone marrow injection of unwashed cord blood following reduced-intensity conditioning
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
| 18 | years-old | <= |
Age-upper limit
| 70 | 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. 2) Patients aged between 35 and 55 years.
4)Patients aged between 55 and 70 years. Patients aged between 18 and 55 years who are not eligible for myeloablative conditioning.
5) Sufficient organ function
5-1) Ejection Fraction >= 50%
5-2) serum total billirubin is needed to be less than 2.5 times the normal upper limit
5-3) serum creatinine level <= 1.5upper 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
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Ogawa |
Organization
Hyogo College of Medicine
Division name
Division of Hematology, Department of Internal Medicine
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya city, Hyogo
TEL
0798-45-6886
masaya@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Okada |
Organization
hyogo college of medicine
Division name
Division of Hematology, Department of Internal Medicine
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya city, Hyogo
TEL
0798-45-6886
Homepage URL
masaya@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
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
Hyogo College of Medicine
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
Tel
+81798456886
masaya@hyo-med.ac.jp
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
| 2011 | Year | 10 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 23 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 23 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 23 | Day |
Date analysis concluded
| 2017 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 12 | Day |
Last modified on
| 2021 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005984
