Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15
1 other identifier
interventional
44
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2010
19 active sites
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
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 30, 2010
CompletedFirst Posted
Study publicly available on registry
August 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedMarch 30, 2017
March 1, 2017
1.8 years
July 30, 2010
March 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Complete response rate in the best overall response assessment for antitumor effect
After cycle 2 and cycle 4
Secondary Outcomes (5)
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.
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.
Adverse events
During the study period
anti-KW-0761 antibody
Before 1st and 5th dosing, 14 days after 8th or last dosing and at the start of post-treatment.
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.
Study Arms (2)
mLSG15
ACTIVE COMPARATORmLSG15 + KW-0761
EXPERIMENTALInterventions
VCAP(Vincristine Sulfate, Cyclophosphamide Hydrate, Doxorubicin Hydrochloride, Prednisolone); AMP(Doxorubicin Hydrochloride, Ranimustine, Prednisolone); VECP(Vindesine Sulfate, Etoposide, Carboplatin, Prednisolone)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
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
Related Publications (1)
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.
PMID: 25733162DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2010
First Posted
August 2, 2010
Study Start
July 1, 2010
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
March 30, 2017
Record last verified: 2017-03