UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018897 |
|---|---|
| Receipt number | R000021866 |
| Scientific Title | Multi-center clinical trial testing efficacy and safety of 1592U89 in patients with relapsed/refractory adult T-cell Leukemia |
| Date of disclosure of the study information | 2015/10/14 |
| Last modified on | 2019/03/12 17:18:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multi-center clinical trial testing efficacy and safety of 1592U89 in patients with relapsed/refractory adult T-cell Leukemia
Acronym
Phase 2 Trial of 1592U89 in patients with relapsed/refractory adult T-cell Leukemia
Scientific Title
Multi-center clinical trial testing efficacy and safety of 1592U89 in patients with relapsed/refractory adult T-cell Leukemia
Scientific Title:Acronym
Phase 2 Trial of 1592U89 in patients with relapsed/refractory adult T-cell Leukemia
Region
| Japan |
Condition
Condition
Adult T-cell leukemia (ATL)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test the efficacy and safety of abacavir in patients with relapsed/refractory acute-, lymphoma- or unfavorable chronic-type adult T-cell leukemia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
response proportion during first 12 weeks of treatment
Key secondary outcomes
overall survival, time-to-treatment-failure, disease control rate, the frequency and grade of adverse events, response proportion accrding to disease subtype, pharmacokinetics
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
abacavir
1800mg/day
endpoints are assessed during first 12 weeks of treatment
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
acute-, lymphoma- or unfavorable chronic-type adult T-cell leukemia.
relapsed after, or refractory to at least one standard chemotherapy regimen.
with at least one measurable lesion, or skin or peripheral blood involvement.
with adequate cardiac, pulmonary, renal and liver function.
Key exclusion criteria
prior treatment with abacavir or AZT
pregnant or lactating women.
active malignancy other than ATL.
previous treatment with autologous or allogeneic transplantation.
positive for HBs antigen.
positive for anti-HBs antibody or anti-HBc antibody and HBV-DNA.
positive for anti-HIV antibody.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akifumi Takaori-Kondo |
Organization
Kyoto University Hospital
Division name
Department of Hematology/Oncology
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo, 606-8507 Kyoto, Japan
TEL
075-751-3152
hemato@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakatsu Hishizawa |
Organization
Kyoto University Hospital
Division name
Department of Hematology/Oncology
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo, 606-8507 Kyoto, Japan
TEL
075-751-3152
Homepage URL
hemato@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
京都大学医学部附属病院(京都府)
長崎大学病院(長崎県)
佐賀大学医学部附属病院(佐賀県)
九州大学病院(福岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 14 | 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
| 2015 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 03 | Day |
Last modified on
| 2019 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021866
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
