UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025856 |
|---|---|
| Receipt number | R000029698 |
| Scientific Title | Phase 1 study to evaluate the safety of dasatinib in relapsed and refractory angioimmunoblastic T-cell lymphoma |
| Date of disclosure of the study information | 2017/01/30 |
| Last modified on | 2018/07/31 13:07:42 |
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Basic information
Public title
Phase 1 study to evaluate the safety of dasatinib in relapsed and refractory angioimmunoblastic T-cell lymphoma
Acronym
Dasatinib safety in AITL
Scientific Title
Phase 1 study to evaluate the safety of dasatinib in relapsed and refractory angioimmunoblastic T-cell lymphoma
Scientific Title:Acronym
Dasatinib safety in AITL
Region
| Japan |
Condition
Condition
angioimmunoblastic T-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The study is designed to evaluate safety of dasatinib in recurrent/refractory angioimmunoblastic T-cell lymphoma (AITL). The primary endpoint is safety, and the secondary endpoint is response rate, complete response rate, progression-free survival, and overall survival.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of dasatinib in AITL
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
dasatinib
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Pathologic diagnosis of AITL is made
(2)Relapse after chemotherapy or SD/PD in the most recent cherapy
(3)Tumor biopsy sample is available
Key exclusion criteria
Treated with other anti-cancer drugs, calcineurin inhibitors, and steroid (excluding 10mg or less predonisolone)
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Chiba |
Organization
University of Tsukuba,Faculty of Medicine
Division name
Department of Hematology
Zip code
Address
1-1-1Tnennodai,Tsukuba Ibaraki
TEL
029-853-3127
schiba-tky@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mamiko Sakata |
Organization
Univercity of Tsukuba,Faculty of Medicine
Division name
Department of Hematology
Zip code
Address
1-1-1Tnennodai,Tsukuba Ibaraki
TEL
029-853-3127
Homepage URL
http://www.ketsunai.com/research/
sakatama-tky@umin.net
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba Hospital
Organization
Division
Category of Funding Organization
Other
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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 30 | 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
| 2016 | Year | 12 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 26 | Day |
Last modified on
| 2018 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029698
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
