UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief 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)
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	Satoshi Yurimoto
Organization	Kyowa Hakko Kirin Co., Ltd.
Division name	Medical Affairs Department
Address	1-9-2, Ohtemachi, Chiyoda-ku, Tokyo,
TEL	07031413339
Email	ma.oncology@kyowa-kirin.co.jp

Public contact
Name of contact person	Satoshi Yurimoto
Organization	Kyowa Hakko Kirin Co., Ltd
Division name	Medical Affairs Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://dx.doi.org/10.1111/bjh.15123
Results	Refer to the article
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