UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007654 |
|---|---|
| Receipt number | R000009024 |
| Scientific Title | Allogeneic Intrabone marrow transplantation using bone marrow cells obtained by usual aspiration method: phase I/II study |
| Date of disclosure of the study information | 2012/04/09 |
| Last modified on | 2012/04/03 14:54:19 |
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Basic information
Public title
Allogeneic Intrabone marrow transplantation using bone marrow cells obtained by usual aspiration method: phase I/II study
Acronym
Allogeneic Intrabone marrow-bone marrow transplantation: phase I/II study
Scientific Title
Allogeneic Intrabone marrow transplantation using bone marrow cells obtained by usual aspiration method: phase I/II study
Scientific Title:Acronym
Allogeneic Intrabone marrow-bone marrow transplantation: phase I/II study
Region
| Japan |
Condition
Condition
chronic myeloid leukemia, acute myeloid leukemia, acute lymphoid leukemia, myelodysplastic syndrome malignant lymphoma
Classification by specialty
| Hematology and clinical oncology | Blood transfusion |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In allgeneic bone marrow transplantation, the expected merits of intrabone marrow injection of bone marrow cells are as follows: 1) Engraftment may be obtained using a small amount of hematopoietic stem cells, 2) The incidence and severity of graft-versus-host disease may be diminished because bone marrow is immunosuppressive environment, 3) Immature hematopietic stem cells, which can not engraft bone marrow by usual intravenous injection method, can engraft to bone marrow. In the present study, the safety of intrabone marrow injection of bone marrow cells will be analyzed as a phase I study, and the usefulness of intrabone marrow transplantation will be analyzed as a phase II study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Primary endpoint in the phase I study is the safety of intrabone marrow transplantation transplantation, and primary endpoint of the phase II study is donor-derived engraftment on day 35.
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
| Maneuver |
Interventions/Control_1
Intrabone marrow injection of bone marrow cells
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. Patients who have a related HLA-identical or HLA-haploidentical donor are eligible. When patients lack an availble unrelated donor who is identical in HLA-A, -B, and -DR antigens, with 0-1 locus mismatch in allele type, HLA-haploidentical donor can be selected. Patients who urgently need transplantation are eligible.
2. Disease and status
a) Chronic myeloid leukemia
1) Second or later chronic state, accelerated phase, or blast crisis
2) Percentage of blast cells in the bone marrow should be < 30%
b) Acute myeloid leukemia
1) Patients who have disease status other than first complete remission, or patients who have a high risk of chromosomal abnormalities, who have transformed disease from myelodysplastic syndrome, or who needed 2 or more round of induction chemotherapy for achieving complete remission are eligible.
2) Percentage of blast cells in the bone marrow should be < 30%
c) Acute lymphoid leukemia
1) Patients who have status other than first complete remission, or patients who have Philadelphia chromosome, or MLL gene abnormalities or who needed 2 or more round of induction chemotherapy for achieving complete remission are eligible.
2) Percentage of blast cells in the bone marrow should be < 30%
d) Myelodysplastic syndrome, Myelodysplasia/ myeloproliferative disease
1) Intermediate-II or high in International Prognostic Factor Scoring System, or relapse
e) Malignant lymphoma
1) Low grade lymphoma: chemorefractory
2) Intermediate risk lymphoma: chemorefractory
3) high grade lymphoma: status other than first complete remission
Key exclusion criteria
1. Performance status: 2 or more in ECOG criteria
2. AST, ALT > 5 x normal limit
3. serum bilirubin level > 2.0 mg/dl
4. serum creatinine level > 2.0 mg/dl
5. SaO2 < 90%
6. Ejection fraction < 50%
7. HBs antigen(+), HIV antibody(+)
8. Active infection
9. presence of myelofibrosis
Target sample size
26
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, Hyogo
TEL
0798-45-6886
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Soma |
Organization
Hyogo College of Medicine
Division name
Division of Hematology, Department of Internal Medicine
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6886
Homepage URL
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
A grant from the Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 09 | 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
| 2011 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 03 | Day |
Last modified on
| 2012 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009024
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