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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009762
Receipt No. R000011438
Scientific Title 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
Date of disclosure of the study information 2013/01/21
Last modified on 2018/10/31

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Basic information
Public title 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
Acronym IVBU1001(BC): Randomized phase II study of once daily ivBu+Cy vs Cy+once daily ivBu
Scientific Title 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
Scientific Title:Acronym IVBU1001(BC): Randomized phase II study of once daily ivBu+Cy vs Cy+once daily ivBu
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 safety and efficacy of allogeneic hematopoietic stem cell transplantation using once daily intravenous busulfan(ivBu) and cyclophosphamide(Cy) as conditioning regimen for patients with AML, MDS and CML, with the comparison of order of application (ivBu+Cy vs Cy+ivBu) using randomized phase II trial design.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Probability of event-free survival at 1 year after transplantation
Key secondary outcomes (1) Incidence of Bearman's grade 2 or higher adverse events which occur from the begining of conditioning regimen to 28 days after transplantation
(2) Cumulative incidence of engraftment at 100 days after transplantation
(3) Cumulative incidence of non-relapse mortality at 100 days after transplantation
(4) Cumulative incidence of SOS(sinusoidal obstrction syndrome) at 100 days after transplantation
(5) Cumulative incidence of grade II-IV acute GVHD at 1 year after transplantation
(6) Cumulative incidence of chronic GVHD at 1 year after transplantation
(7) Probability of overall survival and cumulative incidence of relapse at 1 year after transplantation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Conditioning regimen
Intravenous busulfan 3.2mg/kg/day x 4days + Cyclophosphamide 60mg/kg/day x 2days
Interventions/Control_2 Conditioning regimen
Cyclophosphamide 60mg/kg/day x 2days + Intravenous busulfan 3.2mg/kg/day x 4days
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
55 years-old >
Gender Male and Female
Key inclusion criteria (1) Patients between the age of 16 and 55 at informed consent
(2) Patients diagnosed as AML, MDS, CML who are eigible for allogeneic hematopoietic stem cell transplantation. No limitation of disease status at transplantation. Patients who need chemotherapy for disease control except imatinib, dasatinib and nilotinib for CML are excluded
(3) Patients who have the fixed schedule about the harvest of bone marrow or paripheral blood stem cells from related or unrelated donors who meet the following conditions:
1) HLA-A, B, DRB1 are genetically identical
2) HLA-A and B are genetically identical and 1 locus of HLA-DRB1 is genetically mismatched
(4) Patients whose performance status are 0 or 1 by ECOG criteria
(5) Patients who meet all of the following conditions:
1) SPO2>=94% by room air
2) sCr=<1.5mg/dL
3) T-bil=<1.5mg/dL
4) AST, ALT and ganma-GTP=<3 x upper limit of normal range
5) Absence of abnormal findings of ECG which require therapeutic interventions
6) Ejection fraction of left ventricle>=50% by UCG
(6) 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
Key exclusion criteria (1) Patients with uncontrolled diabetes mellitus in spite of regular use of insulin
(2) Patients with uncontrolled hypertension in spite of use of antihypertensive drugs
(3) Patients who have active infection
(4) Patients who are positive for TPHA, HBV surface antigen or anti-HCV antibody
(5) Patients who are positive for anti-HTLV-I or anti-HIV antibody
(6) Patients who are not evaluated to be able to survive more than 100 days after transplantation
(7) Patients who have coinciding active malignancies
(8) Patients who are pregnant or in the lactation period, and who are not able to, or not willing to prevent conception during the therapeutic period of this clinical trial
(9) Patients who have psychiatric disorder
(10) Patients who have prior hematopoietic stem cell transplantation
(11) Patients who are considered as inappropriate to register by attending physicians
Target sample size 68

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuya Yamashita
Organization National Cacer Center Hospital
Division name Hematopoietic Stem Cell Transplantation Division
Zip code
Address 5-1-1, Tsukiji, Chuo, Tokyo
TEL +81-3-3542-2511
Email 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
Email tayamash@ncc.go.jp

Sponsor
Institute Hematopoietic Stem Cell Transplantation Division, National Cancer Center Hospital
Institute
Department

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
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 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 10 Month 03 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
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 01 Month 12 Day
Last modified on
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011438

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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