NCT01192984

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

1.7 years

First QC Date

August 30, 2010

Last Update Submit

February 28, 2017

Conditions

Peripheral T/NK-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Antitumor effect (best overall response)

Secondary Outcomes (3)

  • 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

Study Arms (1)

KW-0761

EXPERIMENTAL
Biological: KW-0761

Interventions

KW-0761BIOLOGICAL

Intravenously 8 times at 1-week intervals

KW-0761

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Kyushu University Hospital

Fukuoka, Japan

Location

National Kyushu Cancer Center

Fukuoka, Japan

Location

Tokai University Hospital

Isehara, Japan

Location

Imamura Bun-in Hospital

Kagoshima, Japan

Location

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, Japan

Location

Nagasaki University Hospital

Nagasaki, Japan

Location

Aichi Cancer Center Hospital

Nagoya, Japan

Location

Nagoya City University Hospital

Nagoya, Japan

Location

Nagoya Daini Red Cross Hospital,

Nagoya, Japan

Location

Okayama University Hospital

Okayama, Japan

Location

Hokkaido University Hospital

Sapporo, Japan

Location

Tohoku University Hospital

Sendai, Japan

Location

Cancer Institute Hospital

Tokyo, Japan

Location

National Cancer Center Hospital

Tokyo, Japan

Location

Mie University Hospital

Tsu, Japan

Location

Related Publications (1)

  • 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.

    PMID: 24616310DERIVED

MeSH Terms

Interventions

mogamulizumab

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2010

First Posted

September 1, 2010

Study Start

September 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

March 3, 2017

Record last verified: 2017-02

Locations

JP(15)