Clinical trial NCT01192984: Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma
Official title: Phase II Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral T/NK-cell Lymphoma
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-09-01
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Antitumor effect (best overall response)
Secondary outcomes:
measure: Antitumor effect (best response by disease lesion), progression-free survival and overall survival
measure: Adverse events and anti-KW-0761 antibody levels
measure: Plasma KW-0761 concentrations and pharmacokinetic parameters
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukuoka
country: Japan
facility: National Kyushu Cancer Center
city: Isehara
country: Japan
facility: Tokai University Hospital
city: Kagoshima
country: Japan
facility: Imamura Bun-in Hospital
city: Kyoto
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Nagoya
country: Japan
facility: Nagoya Daini Red Cross Hospital,
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
city: Sendai
country: Japan
facility: Tohoku University Hospital
city: Tokyo
country: Japan
facility: Cancer Institute Hospital
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Tsu
country: Japan
facility: Mie University Hospital
Study officials:
References:
citation: 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.