Unique ID issued by UMIN | UMIN000009767 |
---|---|
Receipt number | R000011443 |
Scientific Title | Pharmacokinetic study of busulfan in allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using once daily intravenous busulfan and cyclophosphamide as conditioning regimen |
Date of disclosure of the study information | 2013/01/21 |
Last modified on | 2018/10/31 17:15:46 |
Pharmacokinetic study of busulfan in allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using once daily intravenous busulfan and cyclophosphamide as conditioning regimen
IVBU1001(BC)-PK: Pharmacokinetic study of busulfan in once daily intravenous busulfan and cyclophosphamide
Pharmacokinetic study of busulfan in allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using once daily intravenous busulfan and cyclophosphamide as conditioning regimen
IVBU1001(BC)-PK: Pharmacokinetic study of busulfan in once daily intravenous busulfan and cyclophosphamide
Japan |
acute myeloid leukemia(AML)
myelodysplastic syndrome(MDS)
chronic myelogenous leukemia(CML)
Hematology and clinical oncology |
Malignancy
NO
To investigate pharmakokinetics of busulfan in allogeneic hematopoietic stem cell transplantation using once daily
intravenous busulfan(ivBu) and cyclophosphamide(Cy) as conditioning regimen for patients with AML, MDS and CML, as the ancillary study of randomized phase II study of allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using once daily intravenous busulfan and cyclophosphamide as conditioning regimen (IVBU1001(BC): main study)
Pharmacokinetics
Confirmatory
Pragmatic
Phase II
Proportion of patients who reach the targeted AUC range of busulfan after first and fourth dose
Relationship between pharmacokinetics of busulfan and adverse events
Observational
16 | years-old | <= |
55 | years-old | > |
Male and Female
(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 and patients
themselves
(1) Patients who withdraw the consent to participate in this study
(2) Patients who are considered as
inappropriate to register by attending
physicians
30
1st name | |
Middle name | |
Last name | Takuya Yamashita |
National Cancer Center Hospital
Hematopoietic Stem Cell Transplantation Division
5-1-1, Tsukiji, Chuo, Tokyo
+81-3-3542-2511
tayamash@ncc.go.jp
1st name | |
Middle name | |
Last name | Takuya Yamashita |
National Cancer Center Hospital
Hematopoietic Stem Cell Transplantation Division
5-1-1, Tsukiji, Chuo, TOkyo
+81-3-3542-2511
tayamash@ncc.go.jp
Hematopoietic Stem Cell Transplantation Division, National Cancer Center Hospital
The Ministry of Health, Labor and Welfare
Japanese Governmental office
Japan
NO
国立がん研究センター中央病院(東京都)
2013 | Year | 01 | Month | 21 | Day |
Unpublished
Completed
2012 | Year | 10 | Month | 03 | Day |
2013 | Year | 01 | Month | 21 | Day |
2015 | Year | 04 | Month | 30 | Day |
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
2013 | Year | 01 | Month | 13 | Day |
2018 | Year | 10 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011443
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |