UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009485 |
|---|---|
| Receipt number | R000011147 |
| Scientific Title | Safety and efficacy of allogeneic hematopoietic stem cell transplantation for refractory hematological malignancies with plerixafor-combined myeloablative conditioning |
| Date of disclosure of the study information | 2012/12/06 |
| Last modified on | 2019/02/04 09:27:44 |
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Basic information
Public title
Safety and efficacy of allogeneic hematopoietic stem cell transplantation for refractory hematological malignancies with plerixafor-combined myeloablative conditioning
Acronym
Allogeneic hematopoietic stem cell transplantation with plerixafor-combined conditioning
Scientific Title
Safety and efficacy of allogeneic hematopoietic stem cell transplantation for refractory hematological malignancies with plerixafor-combined myeloablative conditioning
Scientific Title:Acronym
Allogeneic hematopoietic stem cell transplantation with plerixafor-combined conditioning
Region
| Japan |
Condition
Condition
acute leukemia, myelodysplastic syndrome, chronic myelogenous leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety and efficacy of allogeneic hematopoietic stem cell transplantation with plerixafor-combined myeloablative conditiong for refractory hematological malignancies
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events within 28 days after transplantation
Key secondary outcomes
1) neutrophil engraftment
2) red cell and platelet engraftment
3) non-relapse mortality with 28 days after transplantation
4) 1-year overall and non-relapse survivial
5) 1-year relapse rate
6) acute and chronic GVHD
7) Infectous complications
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
Allogeneic hematopoietic stem cell transplantation with plerixafor-combined myeloablative conditioning
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
| 55 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Acute myeloid or lymphoblastic leukemia not in remission or with high-risk cytogenetics
2) Chronic myelogenous leukemia in accelerated phase, blastic crisis, and second chronic phase
3) myelodysplastic syndrome with 10% or greater blast in bone marrow or 5% or greater in peripheral blood
Key exclusion criteria
Moderate or severe dysfunction in major organs
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehiko Mori |
Organization
Keio University School of Medicine
Division name
Division of Hematology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
tmori@a3.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehiko Mori |
Organization
Keio University School of Medicine
Division name
Division of Hematology
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-3353-1211
Homepage URL
tmori@a3.keio.jp
Sponsor or person
Institute
Division of Hematology
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Hematology
Keio University School of Medicine
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
慶應義塾大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 06 | 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 | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 05 | Day |
Last modified on
| 2019 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011147
