UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010546 |
|---|---|
| Receipt number | 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 | 2022/11/07 12:38:43 |
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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
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
chikako_ohwada@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital, Department of Hematology
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 01 | Day |
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
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 19 | Day |
Last modified on
| 2022 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012328
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