UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012648 |
|---|---|
| Receipt number | R000014792 |
| Scientific Title | Feasibility test to treat PhALL patients with autoPBSCT and TKI maintenance therapy |
| Date of disclosure of the study information | 2013/12/21 |
| Last modified on | 2017/02/27 12:02:06 |
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Basic information
Public title
Feasibility test to treat PhALL patients with autoPBSCT and TKI maintenance therapy
Acronym
autoPBSCT and TKI treatment for PhALL
Scientific Title
Feasibility test to treat PhALL patients with autoPBSCT and TKI maintenance therapy
Scientific Title:Acronym
autoPBSCT and TKI treatment for PhALL
Region
| Japan |
Condition
Condition
Ph1-positive acute lymphoblastc leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate safety of autoPBSCT and TKI maintenance therapy for MRD-negative PhALL
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Survival, TRM and non-hematological AE at day 100
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
Treat PhALL patients with both autoPBSCT and tyrosine kinase inhibitor.
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
| 50 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. de novo PhALL who achieved molecular CR
2. 50 to 70 yeas old
3. ECOG 0,1
4. Patients who have ability to undergo autoPBSCT
5. Not applicable alloSCT
6. Written informed consent
Key exclusion criteria
1. Patients who have other active malignant disease
2. Patients who have uncontrolled severe complications
3. Patients who have uncontrolled psychological disease
4. Patients who have dementia
5. Patients who have difficulties to receive scheduled treatment.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanori Teshima |
Organization
Hokkaido University Graduate School of Medicine
Division name
Dept. of Hematology
Zip code
Address
N15 W7, Kita-ku, Sapporo
TEL
011-706-7214
teshima@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Kondo |
Organization
Hokkaido University Graduate School of Medicine
Division name
Dept. of Hematology
Zip code
Address
N15 W7, Kita-ku, Sapporo
TEL
011-706-7214
Homepage URL
t-kondoh@med.hokudai.ac.jp
Sponsor or person
Institute
North Japan Hematology Study Group
Institute
Department
Personal name
Funding Source
Organization
North Japan Hematology Study Group
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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 | 12 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | 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
Management information
Registered date
| 2013 | Year | 12 | Month | 21 | Day |
Last modified on
| 2017 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014792
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/02/27 | [No.013-0023]PhALL 研究実施計画書【130621承認】.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/02/27 | 自主臨床研究終了報告書.doc |
