UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009769
Receipt number R000011445
Scientific Title Pharmacokinetic study of busulfan in allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using once daily intravenous busulfan and fludarabine as conditioning regimen
Date of disclosure of the study information 2013/01/21
Last modified on 2018/10/31 17:18:10

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Basic information

Public title

Pharmacokinetic study of busulfan in allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using once daily intravenous busulfan and fludarabine as conditioning regimen

Acronym

IVBU1002(FB4)-PK: Pharmacokinetic study of busulfan in once daily intravenous busulfan and fludarabine phosphate

Scientific Title

Pharmacokinetic study of busulfan in allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using once daily intravenous busulfan and fludarabine as conditioning regimen

Scientific Title:Acronym

IVBU1002(FB4)-PK: Pharmacokinetic study of busulfan in once daily intravenous busulfan and fludarabine phosphate

Region

Japan


Condition

Condition

acute myeloid leukemia(AML)
myelodysplastic syndrome(MDS)
chronic myelogenous leukemia(CML)

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate pharmakokinetics of
busulfan in allogeneic hematopoietic
stem cell transplantation using once
daily intravenous busulfan(ivBu) and
fludarabine phosphate(Flu) as conditioning regimen for patients with AML, MDS and CML, as the ancillary study of phase II study of allogeneic hematopoietic stem cell
transplantation for patients with myeloid malignancies using once daily intravenous busulfan and fludarabine phosphate as conditioning regimen (IVBU1002(FB4): main study)

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Proportion of patients who reach the
targeted AUC range of busulfan after
first and fourth dose

Key secondary outcomes

Relationship between pharmacokinetics of busulfan and adverse events


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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) Patients who are eligible for the main study and registered to it
(2) Patients who give written informed consent following sufficient explanation. Patients who are under 20 years old are required to give informed consent from both persons with parental authority

Key exclusion criteria

(1) Patients who withdraw the consent to participate in this study
(2) Patients who are considered as inappropriate to register by attending
physicians

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takuya Yamashita

Organization

National Cancer Center Hospital

Division name

Hematopoietic Stem Cell Transplantation Division

Zip code


Address

5-1-1, Tsukiji, Chuo, Tokyo

TEL

+81-3-3542-2511

Email

tayamash@ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takuya Yamashita

Organization

National Cancer Center Hospital

Division name

Hematopoietic Stem Cell Transplantation Division

Zip code


Address

5-1-1, Tsukiji, Chuo, Tokyo

TEL

+81-3-3542-2511

Homepage URL


Email

tayamash@ncc.go.jp


Sponsor or person

Institute

Hematopoietic Stem Cell Transplantation Division, National Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

The Ministry of Health, Labor and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


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

国立がん研究センター中央病院(東京都)


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 21 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

2012 Year 11 Month 28 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 21 Day

Last follow-up date

2015 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Blood sampling is performed at 3, 5, 8 and 24 hours after first dose of ivBu, and at just before and 3 hours after fourth dose. Blood concentration of Bu is measured by gas
chromatograohy and mass spectrometry. AUC is caluculated according to a established method


Management information

Registered date

2013 Year 01 Month 13 Day

Last modified on

2018 Year 10 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011445


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name