UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006540 |
|---|---|
| Receipt number | R000007306 |
| Scientific Title | Safety and efficacy of reduced-intensity myeloablative conditioning regimen with fludarabine and intravenous busulfan for hematological malignancies |
| Date of disclosure of the study information | 2011/10/27 |
| Last modified on | 2024/02/23 15:08:54 |
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Basic information
Public title
Safety and efficacy of reduced-intensity myeloablative conditioning regimen with fludarabine and intravenous busulfan for hematological malignancies
Acronym
Safety and efficacy of reduced-intensity myeloablative conditioning regimen with fludarabine and intravenous busulfan for hematological malignancies
Scientific Title
Safety and efficacy of reduced-intensity myeloablative conditioning regimen with fludarabine and intravenous busulfan for hematological malignancies
Scientific Title:Acronym
Safety and efficacy of reduced-intensity myeloablative conditioning regimen with fludarabine and intravenous busulfan for hematological malignancies
Region
| Japan |
Condition
Condition
Hematological malignancies
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to evaluate safety and efficacy of allogeneic hematopoietic stem cell transplantation using reduced-intensity myeloablative conditioning regimen with fludarabine (180 mg/m2) and intravenous busulfan (12.8 mg/kg) for elderly patients with hematological malignancies
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Disease-free survival at 100 days after transplantation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Conditioning regimen:
Fludarabine 180mg/m2 + intravenous Busulfan 12.8mg/kg + TBI 2Gy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases applicable to reduced-intensity conditioning regimen (age > 55 or having comorbidity)
Key exclusion criteria
Those who are considered as inappropriate to register by attending physicians
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Chiba |
Organization
University of Tsukuba
Division name
Department of Hematology
Zip code
Address
Tennodai 1-1-1, Tsukuba, Ibaraki
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Tsukuba
Division name
Department of Hematology
Zip code
Address
029-853-3127
TEL
Homepage URL
Sponsor or person
Institute
University of Tsukuba, Department of Hematology
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba, Department of Hematology
Organization
Division
Category of Funding Organization
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
| 2011 | Year | 10 | Month | 27 | 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
| 2011 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 14 | Day |
Last modified on
| 2024 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007306
