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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013294
Receipt No. 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

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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
Email 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
Email ma.oncology@kyowa-kirin.co.jp

Sponsor
Institute Kyowa Hakko Kirin Co., Ltd.
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015499

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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