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
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
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
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
