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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010546
Receipt No. R000012328
Scientific Title Safety and efficacy of conditioning regimen with fludarabine and targeted dose intravenous busulfan for elderly patinets
Date of disclosure of the study information 2013/04/19
Last modified on 2016/04/22

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Basic information
Public title Safety and efficacy of conditioning regimen with fludarabine and targeted dose intravenous busulfan for elderly patinets
Acronym Safety and efficacy of conditioning regimen with fludarabine and targeted dose intravenous busulfan for elderly patinets
Scientific Title Safety and efficacy of conditioning regimen with fludarabine and targeted dose intravenous busulfan for elderly patinets
Scientific Title:Acronym Safety and efficacy of conditioning regimen with fludarabine and targeted dose intravenous busulfan for elderly patinets
Region
Japan

Condition
Condition Acute myeloid leukemia, Myelodysplastic syndrome
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of fludarabine 180mg/m2 and targeted dose of intraveneous busulfan for conditioning regimen for hematopoietic stem cell transplantation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Transplant related death in 100 days post-transplant
Key secondary outcomes Event free survival (1-year)
Non-relapse mortality (1-year, 2-year)
Severe nonhematologic toxicity within 28days
Engraftment rate at day 100
Fequency of SOS at day 100
frequency of grade2-4 aGVHD
frequency of chronic GVHD

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 The dose of busulfan is adjusted to acheieve target total daily AUC of 6000 µmol-min/l
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
70 years-old >
Gender Male and Female
Key inclusion criteria Acute myeloid leukemia and myelodysplastic syndrome
age:from 56 to 69 year-old
PS:0-2
No severe organ damages (less than CTCTAE grade 2)
Creatinine clearance higher than 50 ml/min/m2
Cardiac ejection fraction: more than 50%
No oxygen requirement
Aquired written informed consent
Key exclusion criteria Patient who receieved chemotherapy within 4 weeks prior the day of transplantation.
Patients who received gemtuzumab ozogamicin within 3 months prior of transplantation
Patients underwent allogeneic transplantation within 1 year
HCI-CI higher than 3 points
Patients with active double malignancies
Patinets with active infection
Positivith of HIV-Ab, TPHA, HBs-AB, and HCV-Ab
Uncontrolable diabetes and hypertention
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chiaki Nakaseko
Organization Chiba University Hospital
Division name Department of Hematology
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL 043-225-6502
Email chiaki-nakaseko@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chikako Ohwada
Organization Chiba Univeersity Hospital
Division name Department of Hematology
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL +81-43-225-6502
Homepage URL
Email chikako_ohwada@faculty.chiba-u.jp

Sponsor
Institute Chiba University Hospital, Department of Hematology
Institute
Department

Funding Source
Organization Chiba University Hospital, Department of Hematology
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
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

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 19 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 No longer recruiting
Date of protocol fixation
2012 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 01 Day
Last follow-up date
2016 Year 09 Month 30 Day
Date of closure to data entry
2016 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 19 Day
Last modified on
2016 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012328

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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