UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004663
Receipt number R000004311
Scientific Title Intra-bone marrow-bone marrow transplantation (IBM-BMT) with perfusion method
Date of disclosure of the study information 2010/12/03
Last modified on 2011/06/04 10:52:28

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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 -but assessor(s) are 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

Division name

The Department of 1st Internal Medicine

Zip code


Address

2-3-1,Shinmachi,Hirakata-city,Osaka

TEL

072-804-2831

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shinichiro Mori

Organization

Kansai Medical University

Division name

The Department of Hemato-oncology

Zip code


Address

2-3-1,Shinmachi,Hirakata-city,Osaka

TEL

072-804-2831

Homepage URL


Email

morish@hirakata.kmu.ac.jp


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
Department of Hematology

Name of secondary funder(s)



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

関西医科大学付属枚方病院(大阪府)
兵庫医科大学付属病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2010 Year 12 Month 03 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

Terminated

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 12 Month 03 Day

Last modified on

2011 Year 06 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004311


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name