UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018693 |
|---|---|
| Receipt number | R000021638 |
| Scientific Title | Pharmacokinetic study of intravenous busulfan in allogeneic hematopoietic stem cell transplantation for patients using intravenous busulfan and cyclophosphamide or fludarabine as conditioning regimens. |
| Date of disclosure of the study information | 2015/08/20 |
| Last modified on | 2023/06/08 19:58:07 |
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Basic information
Public title
Pharmacokinetic study of intravenous busulfan in allogeneic hematopoietic stem cell transplantation for patients using intravenous busulfan and cyclophosphamide or fludarabine as conditioning regimens.
Acronym
Pharmacokinetic study of intravenous busulfan as conditioning regimens (KSGCT1502)
Scientific Title
Pharmacokinetic study of intravenous busulfan in allogeneic hematopoietic stem cell transplantation for patients using intravenous busulfan and cyclophosphamide or fludarabine as conditioning regimens.
Scientific Title:Acronym
Pharmacokinetic study of intravenous busulfan as conditioning regimens (KSGCT1502)
Region
| Japan |
Condition
Condition
Acute myeloid leukemia (AML),Acute lymphoblastic leukemia (ALL),Myelodysplastic syndrome (MDS), Chronic myeloid leukemia (CML)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the difference of pharmacokinetics (PK) of busulfan between individuals and the influence of concomitant drugs on the PK by PK analysis of intravenous busulfan (every six hours for four days) in allogeneic hematopoietic stem cell transplantation in Japan.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The comparison of AUC of intravenous busulfan in 1st day and in 4th day using busulfan and fludarabine as conditioning regimen.
Key secondary outcomes
The comparison of pharmacokinetics of busulfan in Flu/Bu and Bu/CY.
The difference of individual pharmacokinetics of intravenous busulfan in 1st day and 4th day in Flu/Bu.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who received 1st allogeneic hematopoietic stem cell transplantation using Flu/ivBu or ivBu/CY.
2. Busulfan is given intravenously (0.8mg/kg) every six hours for four days (total dose 12.8mg/kg).
3. Patients diagnosed AML, ALL, MDS, CML. No limitation of disease status at transplantation.
4. Patients more than the age of 15 years at informed consents.
5. No limitation of stem cell source.
Key exclusion criteria
None
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shin-ichiro |
| Middle name | |
| Last name | Okamoto |
Organization
Kanto Study Group for Cell Therapy
Division name
Chairman
Zip code
104-0031
Address
Tokyo
TEL
03-6225-2040
ksgctdc@ksgct.net
Public contact
Name of contact person
| 1st name | Kikuchi |
| Middle name | |
| Last name | Taku |
Organization
Kanto Study Group for Cell Therapy
Division name
Trial Office
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
taku_k_1123@mac.com
Sponsor or person
Institute
Kanto Study Group for Cell Therapy
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
Keio
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
Tel
03-3353-1211
ksgctdc@ksgct.net
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 20 | 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
| 2015 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Bu has a narrow therapeutic window. Low Bu exposure is associated with graft rejection and relapse. On the other hand, high Bu exposure is associated with some adverse events including SOS and central nervous system toxicity and so on. Previous reports showed Flu reduced the clearance of Bu and resulted increasing the AUC of Bu. Previous reports showed CY does not interfere PK of Bu, and Bu does not interfere PK of Flu. Although Bu is widely used in conditioning regimens for hematopoietic stem cell transplantation, the data of PK of Bu has not been addressed well in Japan population. To evaluate the PK of Bu (every six hours for four days), it might make a contribution to better outcomes of allogeneic hematopoietic stem cell transplantation.
Management information
Registered date
| 2015 | Year | 08 | Month | 17 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021638
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