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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018897
Receipt No. 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

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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
Email 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
Email hemato@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.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


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