Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15

Adult T-cell Leukemia-Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01173887
• Other study ID #: 0761-003
• Status: Completed
• Phase: Phase 2
• First received: July 30, 2010
• Last updated: March 29, 2017
• Start date: July 2010
• Est. completion date: April 2012

Study information

• Verified date: March 2017
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult T-cell Leukemia-Lymphoma
• Leukemia
• Leukemia, T-Cell
• Leukemia-Lymphoma, Adult T-Cell
• Lymphoma

Intervention

Drug:
• VCAP/AMP/VECP(mLSG15)
VCAP(Vincristine Sulfate, Cyclophosphamide Hydrate, Doxorubicin Hydrochloride, Prednisolone); AMP(Doxorubicin Hydrochloride, Ranimustine, Prednisolone); VECP(Vindesine Sulfate, Etoposide, Carboplatin, Prednisolone)

Biological:
• KW-0761
VCAP/AMP/VECP(mLSG15) + KW-0761

Locations

Country	Name	City	State
Japan	Fukuoka University Hospital	Fukuoka
Japan	Kyushu University Hospital	Fukuoka
Japan	National Kyushu Cancer Center	Fukuoka
Japan	Imamura Bun-in Hospital	Kagoshima
Japan	Kagoshima University Hospital	Kagoshima
Japan	Kokura Memorial Hospital	Kitakyushu
Japan	Kumamoto University Hospital	Kumamoto
Japan	National Hospital Organization Kumamoto Medical Center	Kumamoto
Japan	NTT West Japan Kyushu Hospital	Kumamoto
Japan	Nagasaki University Hospital	Nagasaki
Japan	The Japanese Red Cross Nagasaki Genbaku Hospital	Nagasaki
Japan	Aichi Cancer Center Hospital	Nagoya
Japan	Nagoya City University Hospital	Nagoya
Japan	Oita Prefectural Hospital	Oita
Japan	Heartlife Hospital	Okinawa
Japan	National Hospital Organization Nagasaki Medical Center	Omura
Japan	Sasebo City General Hospital	Sasebo
Japan	National Cancer Center Hospital	Tokyo
Japan	Ehime University Hospital	Toon

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate in the best overall response assessment for antitumor effect		After cycle 2 and cycle 4
Secondary	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		After cycle 2 and cycle 4.
Secondary	Progression-free survival and Overall survival		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.
Secondary	Adverse events		During the study period
Secondary	anti-KW-0761 antibody		Before 1st and 5th dosing, 14 days after 8th or last dosing and at the start of post-treatment.
Secondary	Plasma KW-0761 concentrations and pharmacokinetic parameters		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.