UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014077
Receipt number R000016385
Scientific Title Clinical evaluation of efficacy of dose-modified intravenous busulfan in allogeneic hematopoietic stem cell transplantation for hematological malignancy.
Date of disclosure of the study information 2014/06/15
Last modified on 2022/06/02 09:57:57

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Basic information

Public title

Clinical evaluation of efficacy of dose-modified intravenous busulfan in allogeneic hematopoietic stem cell transplantation for hematological malignancy.

Acronym

Efficacy of dose-modified intravenous busulfan

Scientific Title

Clinical evaluation of efficacy of dose-modified intravenous busulfan in allogeneic hematopoietic stem cell transplantation for hematological malignancy.

Scientific Title:Acronym

Efficacy of dose-modified intravenous busulfan

Region

Japan


Condition

Condition

Hematological malignancy

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of safety and efficacy of dose-modified intravenous busulfan by prospectively analyzing busulfan concentration and subsequent dose adjustment in allogeneic hematopoietic stem cell transplantation for hematological malignancy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

The proportion of patients with event-free survival in 100 day after transplantation

Key secondary outcomes

The proportion 0f patients with engraftment in 100 day after transplantation
The proportion of patients with grade3 or 4 adverse effects in 100 day after transplantation
The proportion of patients with non-relapase mortality in 100 day and 12 month after transplantation
The proportion of patients with relapase in 100 day and 12 month 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

dose-modified intravenous busulfan

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

16 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

1. Hematological malignancy for AML, MDS, CML and ALL
2. Performance status(PS, ECOG) of 0-2
3. Patients without major organ dysfunction
4. T.Bil less than 2.0 mg/dL
5. AST and ALT less than 3 upper limit of the normal range
6. SCr less than 2.0mg/dl
7. Heart ejection fraction more than 50%
8. SpO2 more than 93%
9. Estimated life expectancy of at least 3 months
10. Patients requird to have an appropriate donor identified before enrollment.
(1) HLA-matched related or unrelated donor
(2) 1 HLA-mismatched related or unrelated donor
(3) Cord blood with nucleated cell counts more than 2 107/kg and mismatched HLA less than 2
11. Ability to provide informed consent.

Key exclusion criteria

1. positive for anti-HIV antibody
2. positive for Hbs antigen
3. active another malignancy
4. uncontrollable psychological disorders
5. uncontrollable active infection
6. positive for donor-specific HLA antibody
7. previous history of hematopoietic stem cell transplantation
8. known hypersensitivity to busulfan
9. pregnant women
10. Patients judged as inappropriate for this study by physicians

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Akifumi
Middle name
Last name Takaori-Kondo

Organization

Kyoto University Hospital

Division name

Department of Hematology and Oncology

Zip code

606-8507

Address

54 Shogoin Kawaharacho, Sakyo-ku, Kyoto-shi, Kyoto

TEL

075-751-3150

Email

atakaori@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Tadakazu
Middle name
Last name Kondo

Organization

Kyoto University Hospital

Division name

Department of Hematology and Oncology

Zip code

606-8507

Address

54 Shogoin Kawaharacho, Sakyo-ku, Kyoto-shi, Kyoto

TEL

075-366-7550

Homepage URL

http://www.kuhp.kyoto-u.ac.jp/~hemonc/research/trial.html

Email

tadakazu@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Hospital, Department of Hematology and Oncology

Institute

Department

Personal name



Funding Source

Organization

none

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

Ethics Committee, Graduate School and Faculty of Medicine, Kyoto University

Address

54 Shogoin Kawaharacho, Sakyo-ku, Kyoto-shi, Kyoto

Tel

075-753-9470

Email

ethcom@kuhp.kyoto-u.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

京都大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2014 Year 06 Month 15 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

Completed

Date of protocol fixation

2014 Year 05 Month 09 Day

Date of IRB

2014 Year 06 Month 26 Day

Anticipated trial start date

2014 Year 07 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 05 Month 27 Day

Last modified on

2022 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016385


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name