UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015426 |
|---|---|
| Receipt number | R000017937 |
| Scientific Title | Assessment of safety and effectiveness of once-daily administration of intravenous busulfan for allogeneic hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2018/10/16 10:55:50 |
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Basic information
Public title
Assessment of safety and effectiveness of once-daily administration of intravenous busulfan for allogeneic hematopoietic stem cell transplantation
Acronym
Once-daily ivBu for Allo-HSCT
Scientific Title
Assessment of safety and effectiveness of once-daily administration of intravenous busulfan for allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym
Once-daily ivBu for Allo-HSCT
Region
| Japan |
Condition
Condition
Hematological diseases
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and effectiveness of once-daily ivBu (3.2mg/kg) in allogeneic hematopoietic stem cell transplantation for those with hematological diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
(1) Incidence of survival and donor cell engraftment at day 100 post-transplant
(2) Incidence of achieving complete donor type chimerism at day 100 post transplant
(3) Event-free survival rate at day 365 post-transplant
(4) Overall survival rate at day 365 post-transplant
(5) Incidences of acute or chronic GVHD up to day 365 post-transplant
Key secondary outcomes
(1) Incidence of adverse events up to day 100 post-transplant
(2) Non-relapse mortality rate at day 100 post-transplant
(3) Incidence of sinusoidal obstruction syndrome up to day 100 post-transplant
(4) Rate of achieving optimal ivBu AUC (3,600-6,000micromolxmin/ml)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
3.2mg/kg of IvBu will be administered intravenously for 3 hours once-daily.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients who are suffering from hematological diseases (acute leukemia, myelodysplastic syndrome, chronic myeloid leukemia, myeloproliferative disorders, malignant lymphoma), and who need allogeneic hematopoietic stem cell transplantation.
(2) Patients who have appropriate donors available (related, unrelated donor, cord blood donor).
(3) Patients who gave written informed consent.
Key exclusion criteria
(1) Patients who have active malignant diseases other than hematological diseases
(2) Patients who have poorly controlled psychiatric diseases
(3) Patients who have active infection
(4) Patients who have history of hypersensitivity against ivBu
(5) Patients who are pregnant or suspected pregnancy, or are lactating
(6) Patients who are considered to be not appropriate candidates for participation by attending physicians
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Taniguch7i |
Organization
Toranomon Hospital
Division name
Department of Hematology
Zip code
Address
2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan
TEL
+81-3-3588-1111
taniguchi-s@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoyuki Uchida |
Organization
Toranomon Hospital
Division name
Department of Hematology
Zip code
Address
2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan
TEL
+81-3-3588-1111
Homepage URL
nuchida@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Okinaka Memorial Institute for Medical Research
Organization
Division
Category of Funding Organization
Non profit foundation
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
虎の門病院/Toranomon Hospital
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 13 | Day |
Last modified on
| 2018 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017937
