Study of KW-0761 in Subjects With CCR4-positive Periphera... | NCT01192984

Studies
Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma

NCT01192984

Sponsor

Kyowa Kirin Co., Ltd.

Status

Completed

Last Update Posted

Mar 3, 2017Actual

Enrollment

38Actual

Phase

Phase 2

Conditions

Peripheral T/NK-cell Lymphoma

Interventions

KW-0761

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Aug 30, 2010

First Submission Date that Met QC Criteria

Aug 31, 2010

First Posted Date

Sep 1, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2017

Last Update Posted Date

Mar 3, 2017Actual

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy of KW-0761 intravenously administered eight times at one-week intervals in patients with CCR4-positive peripheral T/NK-cell lymphoma. The primary objective is to assess the antitumor effect in terms of best overall response, while the secondary objectives are to assess the antitumor effect in terms of best response by disease lesion, to assess the progression-free survival and to assess the overall survival. The safety and pharmacokinetic profiles of KW-0761 will be also evaluated.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Label	Type	Description	Intervention Names
KW-0761	Experimental		Biological: KW-0761

Name	Type	Description	Arm Group Labels	Other Names
KW-0761	Biological	Intravenously 8 times at 1-week intervals	KW-0761

Measure	Description	Time Frame
Antitumor effect (best overall response)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with hematologically or pathohistologically diagnosed peripheral T/NK-cell lymphoma
Subjects who have been positive for CCR4
Subjects who received one or more chemotherapy regimens
Subjects who relapse after achieving complete response, uncertain complete response or partial response by the last chemotherapy
Subjects who have an interval of 4 weeks or more between the last day of the prior therapy and the scheduled day of the first KW-0761 treatment
Subjects with nodal lesions, extranodal lesions and/or cutaneous lesions
Subjects who have a performance status of 0 to 2
Subjects who are negative for HBs antigen and reported as "not detected" for HBV-DNA
Subjects who are negative for anti-HCV antibody
Subjects who have normal function of the major organs
Subjects who have given written voluntary informed consent to participate in the study

Exclusion Criteria:

Subjects who underwent transplant therapy such as hematopoietic stem-cell transplantation (Subjects who underwent autologous hematopoietic stem-cell transplantation following chemotherapy will not be excluded)
Subjects who are known carriers of HIV
Subjects who have active multiple cancer
Subjects who have a history of allergic reactions to therapeutic antibodies
Subjects requiring continuous systemic treatment with steroid
Subjects who require emergency radiotherapy for treating the symptoms caused by bulky masses at enrollment or who may require such radiotherapy after the start of the study
Subjects who are pregnant, lactating or of childbearing potential, or who are planning to have children

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Kyushu University Hospital		Fukuoka			Japan
National Kyushu Cancer Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24616310	Derived	Ogura M, Ishida T, Hatake K, Taniwaki M, Ando K, Tobinai K, Fujimoto K, Yamamoto K, Miyamoto T, Uike N, Tanimoto M, Tsukasaki K, Ishizawa K, Suzumiya J, Inagaki H, Tamura K, Akinaga S, Tomonaga M, Ueda R. Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol. 2014 Apr 10;32(11):1157-63. doi: 10.1200/JCO.2013.52.0924. Epub 2014 Mar 10.

Measure	Description	Time Frame
Antitumor effect (best response by disease lesion), progression-free survival and overall survival
Adverse events and anti-KW-0761 antibody levels
Plasma KW-0761 concentrations and pharmacokinetic parameters