UMIN-CTR Clinical Trial

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

Hematological malignancy

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kyoto University Hospital, Department of Hematology and Oncology

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

京都大学医学部附属病院

Date of disclosure of the study information

2014

Year

06

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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