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

NCT ID: NCT01173887

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-04-30

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.

Conditions

Adult T-cell Leukemia-Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mLSG15

Group Type: ACTIVE_COMPARATOR

VCAP/AMP/VECP(mLSG15)

Intervention Type: DRUG

VCAP(Vincristine Sulfate, Cyclophosphamide Hydrate, Doxorubicin Hydrochloride, Prednisolone); AMP(Doxorubicin Hydrochloride, Ranimustine, Prednisolone); VECP(Vindesine Sulfate, Etoposide, Carboplatin, Prednisolone)

mLSG15 + KW-0761

Group Type: EXPERIMENTAL

KW-0761

Intervention Type: BIOLOGICAL

VCAP/AMP/VECP(mLSG15) + KW-0761

Interventions

VCAP/AMP/VECP(mLSG15)

VCAP(Vincristine Sulfate, Cyclophosphamide Hydrate, Doxorubicin Hydrochloride, Prednisolone); AMP(Doxorubicin Hydrochloride, Ranimustine, Prednisolone); VECP(Vindesine Sulfate, Etoposide, Carboplatin, Prednisolone)

Intervention Type: DRUG

KW-0761

VCAP/AMP/VECP(mLSG15) + KW-0761

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Heartlife Hospital

Okinawa, , Japan

Oita Prefectural Hospital

Ōita, , Japan

National Hospital Organization Nagasaki Medical Center

Ōmura, , Japan

Sasebo City General Hospital

Sasebo, , Japan

National Cancer Center Hospital

Tokyo, , Japan

Ehime University Hospital

Tōon, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 25733162 (View on PubMed)

Other Identifiers

0761-003

Identifier Type: -

Identifier Source: org_study_id