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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000015426
Receipt No. 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

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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
Email 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
Email nuchida@toranomon.gr.jp

Sponsor
Institute Toranomon Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017937

Research Plan
Registered date File name
2017/04/16 20161031ivBu1日1回院内研究実施計画書 (観察期間短縮)v3.0.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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