UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016287 |
|---|---|
| Receipt number | R000018850 |
| Scientific Title | Indication of allogenic hematopoietic stem cell transplantation for adult patients with Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia in first remission: Retrospective analysis |
| Date of disclosure of the study information | 2015/01/21 |
| Last modified on | 2015/01/20 20:08:43 |
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Basic information
Public title
Indication of allogenic hematopoietic stem cell transplantation for adult patients with Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia in first remission: Retrospective analysis
Acronym
Allogenic HCT for Ph-negative ALL
Scientific Title
Indication of allogenic hematopoietic stem cell transplantation for adult patients with Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia in first remission: Retrospective analysis
Scientific Title:Acronym
Allogenic HCT for Ph-negative ALL
Region
| Japan |
Condition
Condition
Adults with philadelphia chromosome-negative B-cell acute lymphoblastic leukemia in first remission
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm indication of allogenic HCT for adults with philadelphia chromosome-negative B-cell ALL in 1CR by retrospective analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Event free survival of chemotherapy alone or allogenic HCT
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Inclusion criteria for this study:
(1) diagnosis of Philadelphia chromosome-negative B-cell ALL according to WHO classification (2008) between January 2001 and October 2014;
(2) ages >= 16 and <= 70 years;
(3) achievement of first remission
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Yokota |
Organization
Chiba Aoba Municipal Hospital
Division name
Department of Hematology
Zip code
Address
1273-2 Aoba-cho, Chuo-ku, Chiba 260-0852, Japan
TEL
043-227-1131
taroyok@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Yokota |
Organization
Chiba Aoba Municipal Hospital
Division name
Department of Hematology
Zip code
Address
1273-2 Aoba-cho, Chuo-ku, Chiba 260-0852, Japan
TEL
043-227-1131
Homepage URL
taroyok@gmail.com
Sponsor or person
Institute
Chiba Aoba Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2015 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective multicenter analysis
Management information
Registered date
| 2015 | Year | 01 | Month | 20 | Day |
Last modified on
| 2015 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018850
