UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029115
Receipt number R000033295
Scientific Title A prospective feasibility study of allogeneic hematopoietic stem cell transplantation using once daily intravenous busulfan and fludarabine as conditioning regimen
Date of disclosure of the study information 2017/09/12
Last modified on 2019/09/17 14:05:58

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Basic information

Public title

A prospective feasibility study of allogeneic hematopoietic stem cell transplantation using once daily intravenous busulfan and fludarabine as conditioning regimen

Acronym

Flu plus Bu Once Daily

Scientific Title

A prospective feasibility study of allogeneic hematopoietic stem cell transplantation using once daily intravenous busulfan and fludarabine as conditioning regimen

Scientific Title:Acronym

Flu plus Bu Once Daily

Region

Japan


Condition

Condition

hematological malignancy

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the feasibility of once daily busulfan in allogeneic hematopoietic stem cell transplantation in patients with hematological malignancy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Engraftment rate

Key secondary outcomes

(1) 100 day non-relapse mortality rate
(2) 100 day SOS rate
(3) 1 year overall survival, relapse rate


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Once daily intravenous busulfan as conditioning regimen for allogeneic hematopoietic stem cell transplantation

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) 18 years or older, and younger than 70 years
(2) patient with hematological malignancy with an indication of allogeneic HSCT
(3) Allogeneic BMT or PBSCT from an HLA-matched or 1-locus mismatched donor determined by 8 loci including HLA-A, B, C, DRB1 loci
(4) ECOG PS 0 or 1
(5) Informed consent

Key exclusion criteria

No exclusion criteria

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Shigeo
Middle name
Last name Fuji

Organization

Osaka International Cancer Institute

Division name

Department of Hematology

Zip code

5418567

Address

3-1-69, Otemae, Chuo-ku, Osaka-city, Osaka

TEL

+81-6-6945-1181

Email

fuji-si@mc.pref.osaka.jp


Public contact

Name of contact person

1st name Shigeo
Middle name
Last name Fuji

Organization

Osaka International Cancer Institute

Division name

Department of Hematology

Zip code

5418567

Address

3-1-69, Otemae, Chuo-ku, Osaka-city, Osaka

TEL

+81-6-6945-1181

Homepage URL


Email

fuji-si@mc.pref.osaka.jp


Sponsor or person

Institute

Osaka International Cancer Institute

Institute

Department

Personal name



Funding Source

Organization

Osaka International Cancer Institute

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka International Cancer Institute, Clinical Research Center

Address

3-1-69, Otemae, Chuo-ku, Osaka, Japan

Tel

06-6945-1181

Email

rinri01@opho.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

大阪国際がんセンター


Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 12 Day


Related information

URL releasing protocol

NA

Publication of results

Unpublished


Result

URL related to results and publications

NA

Number of participants that the trial has enrolled

0

Results

Because the new treatment schedule was approved by the government, we stopped the study which assessed the feasibility of the same schedule of administration.

Results date posted

2019 Year 09 Month 17 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

NA

Participant flow

NA

Adverse events

NA

Outcome measures

NA

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2017 Year 09 Month 07 Day

Date of IRB

2017 Year 09 Month 07 Day

Anticipated trial start date

2017 Year 09 Month 12 Day

Last follow-up date

2018 Year 07 Month 10 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 09 Month 12 Day

Last modified on

2019 Year 09 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033295


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name