UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013294 |
|---|---|
| Receipt number | R000015499 |
| Scientific Title | A prognostic study of patient who completed Study 0761-003; a randomized late phase II study of VCAP/AMP/VECP (mLSG15) and mLSG15+KW-0761 in patients with CCR4-positive adult T-Cell leukemia-lymphoma (untreated primary disease) |
| Date of disclosure of the study information | 2014/03/01 |
| Last modified on | 2018/04/17 09:38:56 |
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Basic information
Public title
A prognostic study of patient who completed Study 0761-003; a randomized late phase II study of VCAP/AMP/VECP (mLSG15) and mLSG15+KW-0761 in patients with CCR4-positive adult T-Cell leukemia-lymphoma (untreated primary disease)
Acronym
A prognostic study of patient who completed Study 0761-003; a randomized late phase II study of VCAP/AMP/VECP (mLSG15) and mLSG15+KW-0761 in patients with CCR4-positive adult T-Cell leukemia-lymphoma (untreated primary disease)
Scientific Title
A prognostic study of patient who completed Study 0761-003; a randomized late phase II study of VCAP/AMP/VECP (mLSG15) and mLSG15+KW-0761 in patients with CCR4-positive adult T-Cell leukemia-lymphoma (untreated primary disease)
Scientific Title:Acronym
A prognostic study of patient who completed Study 0761-003; a randomized late phase II study of VCAP/AMP/VECP (mLSG15) and mLSG15+KW-0761 in patients with CCR4-positive adult T-Cell leukemia-lymphoma (untreated primary disease)
Region
| Japan |
Condition
Condition
Adult T-cell leukemia-lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study the prognosis of patients included in the efficacy analysis set in Study 0761-003. The data will be compared with those obtained during Study 0761-003 to update survival data (progression-free survival and overall survival). Data on post-treatment after study treatment in Study 0761-003 (mogamlizmab, mLSG15) will also be collected to investigate if there are any assosiactions with prognosis.
Basic objectives2
Others
Basic objectives -Others
This is a prognostic study.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival
Overall survival
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who participated in Study 0761-003.
Key exclusion criteria
None
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Yurimoto |
Organization
Kyowa Hakko Kirin Co., Ltd.
Division name
Medical Affairs Department
Zip code
Address
1-9-2, Ohtemachi, Chiyoda-ku, Tokyo,
TEL
07031413339
ma.oncology@kyowa-kirin.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Yurimoto |
Organization
Kyowa Hakko Kirin Co., Ltd
Division name
Medical Affairs Department
Zip code
Address
1-9-2, Ohtemachi, Chiyoda-ku, Tokyo,
TEL
07031413339
Homepage URL
ma.oncology@kyowa-kirin.co.jp
Sponsor or person
Institute
Kyowa Hakko Kirin Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kyowa Hakko Kirin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://dx.doi.org/10.1111/bjh.15123
Number of participants that the trial has enrolled
Results
Refer to the article
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 | 10 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prognostic study.
Management information
Registered date
| 2014 | Year | 02 | Month | 27 | Day |
Last modified on
| 2018 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015499
