Clinical trial NCT01173887: Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15
Official title: Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma (Untreated Primary Disease)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adult T-cell Leukemia-Lymphoma
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-08-02
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, open-label, parallel-group study to compare mLSG15 + KW-0761 to mLSG15 in subjects with CCR4-positive adult T-cell leukemia-lymphoma (untreated primary disease). The primary variable is an efficacy of KW-0761 used as an add-on therapy to mLSG15 as measured in terms of complete response rate (CR/CRu) in the best overall response assessment for antitumor effect. The secondary variables include response rate (CR/CRu/PR) in the best overall response assessment for antitumor effect, complete or response rates by lesion site in the best overall response assessment for antitumor effect, progression-free survival and overall survival. The safety and pharmacokinetic profiles of KW-0761 will be also determined.


Eligibility criteria: Inclusion Criteria:

* Subjects who have been positive for serum anti-human T-cell lymphotropic virus type I antibody
* Subjects with hematologically or pathohistologically confirmed as peripheral lymphoid tumor which surface antigen analysis has identified to be of T-cell origin
* Subjects who have been classified into acute subtype, the lymphoma subtype or chronic subtype with poor prognostic factors
* Subjects who have been positive for CCR4 by CCR4 expression analysis
* Subjects who have never been treated for adult T-cell leukemia-lymphoma
* Subjects who have presented enlarged lymph nodes, tumor nodules in extranodal organs, abnormal lymphocytes in peripheral blood or cutaneous lesions
* Subjects with a performance status of 0 to 2
* Subjects who have been negative for HBs antigen and anti-HCV antibody
* Subjects who have given written voluntary informed consent to participate in the study

Exclusion Criteria:

* Subjects who are scheduled for transplant therapy such as hematopoietic stem-cell transplantation
* Subjects who had myocardial infarction within 12 months before study enrollment or who have cardiac disease that may worsen during treatment with doxorubicin
* Subjects who have been positive for anti-HIV antibody
* Subjects with active multiple cancer
* Subjects with a history of allergic reactions to therapeutic antibodies
* Subjects who require emergency radiotherapy for treating the symptoms caused by bulky masses 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: Complete response rate in the best overall response assessment for antitumor effect
timeFrame: After cycle 2 and cycle 4
Secondary outcomes:
measure: Response rate in the best overall response assessment for antitumor effect, complete or response rates by lesion site in the best overall response assessment for antitumor effect
timeFrame: After cycle 2 and cycle 4.
measure: Progression-free survival and Overall survival
timeFrame: During the study period at least once every two months in the first year and once every three months in the second and subsequent years.
measure: Adverse events
timeFrame: During the study period
measure: anti-KW-0761 antibody
timeFrame: Before 1st and 5th dosing, 14 days after 8th or last dosing and at the start of post-treatment.
measure: Plasma KW-0761 concentrations and pharmacokinetic parameters
timeFrame: Before and after 1st, 2nd, 3rd, 4th, 5th, 6th, 7th and 8th dosing, 14 days after 8th or last dosing, and at the start of post-treatment.
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukuoka
country: Japan
facility: National Kyushu Cancer Center
city: Kagoshima
country: Japan
facility: Imamura Bun-in Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Kumamoto
country: Japan
facility: NTT West Japan Kyushu Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Nagasaki
country: Japan
facility: The Japanese Red Cross Nagasaki Genbaku Hospital
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Oita
country: Japan
facility: Oita Prefectural Hospital
city: Okinawa
country: Japan
facility: Heartlife Hospital
city: Omura
country: Japan
facility: National Hospital Organization Nagasaki Medical Center
city: Sasebo
country: Japan
facility: Sasebo City General Hospital
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Toon
country: Japan
facility: Ehime University Hospital
Study officials:
References:
citation: Ishida T, Jo T, Takemoto S, Suzushima H, Uozumi K, Yamamoto K, Uike N, Saburi Y, Nosaka K, Utsunomiya A, Tobinai K, Fujiwara H, Ishitsuka K, Yoshida S, Taira N, Moriuchi Y, Imada K, Miyamoto T, Akinaga S, Tomonaga M, Ueda R. Dose-intensified chemotherapy alone or in combination with mogamulizumab in newly diagnosed aggressive adult T-cell leukaemia-lymphoma: a randomized phase II study. Br J Haematol. 2015 Jun;169(5):672-82. doi: 10.1111/bjh.13338. Epub 2015 Mar 2.