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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007654
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Hyogo College of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009024

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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