The purpose of the study is to evaluate the efficacy and safety of mogamulizumab (KW-0761) in chinese subjects with mycosis fungoides or sézary syndrome previously treated with systemic therapy
This is an open-label, multicenter, single arm study. This study consists of three parts: the Pretreatment Period, the Treatment Period, and the Follow-up Period. Subjects who meet all of eligibility criteria by the screening examination will be enrolled into the study, and start treatment with mogamulizumab within 30 days after obtaining consent. Mogamulizumab will be administered at the dose of 1.0 mg/kg as an intravenous (iv) infusion over at least 1 hour on Days 1, 8, 15, and 22 of Cycle 1 and on Days 1 and 15 of subsequent cycles. Each treatment cycle is set as 28 days. Subjects will continue the treatment of mogamulizumab until any of the criteria for study withdrawal is met. After stopping treatment, the end-of treatment examination will be conducted within 30 days after the last dose.The primary efficacy analysis will be conducted once all subjects terminate treatment by the confirmation of PD/drug intolerance/unacceptable toxicity or 12 months after the date of the first mogamulizumab administration of the last subject of entire study, whichever comes first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Mogamulizumab will be administered at the dose of 1.0 mg/kg as an intravenous (iv) infusion over at least 1 hour on Days 1, 8, 15, and 22 of Cycle 1 and on Days 1 and 15 of subsequent cycles. Each treatment cycle is set as 28 days. Subjects will continue the treatment of mogamulizumab until any of the criteria for study withdrawal is met.
Peking University First Hospital, Department of Dermatology and Venereology
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center, Department of Medical Oncology
Guangzhou, Guangdong, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Overall Response Rate
The ORR was defined as the count of subjects who had a confirmed CR or PR, defined as documented CR or PR per Global Composite Response Score that was confirmed by a subsequent observation at least 4 weeks later. Overall Response Rate was determined based on the response in all compartments (lymph nodes, skin, peripheral blood, and viscera), referencing Olsen, 2011 as follows: Complete Response (CR) = complete disappearance of all clinical evidence of disease; Partial Response (PR) = regression of measurable disease; Stable Disease (SD) = failure to attain CR, PR, or PD; Progressive Disease (PD) = PD in any compartment; Relapse = recurrence of disease in prior CR in any compartment.
Time frame: At the end of each cycle (each cycle is 28 days) until progression up to 29 months;
Skin disease response rate;
Skin disease will be evaluated using the modified SWAT. The detailed response criteria (CR, PR, PD, SD) is defined in Olsen 2011. Complete response (CR) or partial response (PR) will be regarded as response. Response rate is calculated by Subjects who confirmed response/Total subjects
Time frame: At the end of each cycle (each cycle is 28 days) until progression up to 29 months;
Lymth nodes response rate
Lymph nodes status will be evaluated by enhanced computed tomography (CT). The detailed response criteria (CR, PR, PD, SD) is defined in Olsen 2011. Complete response (CR) or partial response (PR) will be regarded as response. Response rate is calculated by Subjects who confirmed response/Total subjects
Time frame: At the end of each cycle (each cycle is 28 days) until progression up to 29 months;
Visceral metastases response rate;
Visceral disease status will be evaluated by enhanced computed tomography (CT). The detailed response criteria (CR, PR, PD, SD) is defined in Olsen 2011. Complete response (CR) or partial response (PR) will be regarded as response. Response rate is calculated by Subjects who confirmed response/Total subjects.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
ZheJiang Cancer Hospital
Hangzhou, Zhejiang, China
First Affiliated Hospital of Zhengzhou University
Henan, Zhengzhou, China
Time frame: At the end of each cycle (each cycle is 28 days) until progression up to 29 months;
Blood disease response rate;
The response in blood will be assessed by flow cytometry. The detailed response criteria (CR, PR, PD, SD) is defined in Olsen 2011. Complete response (CR) or partial response (PR) will be regarded as response. Response rate is calculated by Subjects who confirmed response/Total subjects.
Time frame: At the end of each cycle (each cycle is 28 days) until progression up to 29 months;
Progression Free Survival
PFS is defined as the time from the first day of a treatment until documented progression or death. Progression was defined based on Olsen (2011).
Time frame: Up to 32 months.
Duration of response (DOR)
The DOR is defined as the time from the date that criteria for CR or PR are met (whichever is first recorded) until the first date that PD or death is objectively documented. Subjects who still continue response at the time of analysis will be censored at the day of their last tumor assessment (from any compartment).
Time frame: Up to 32 months.
Time to response (TTR)
TTR is defined as the time from the date of first dose to the date that criteria for CR or PR are met (whichever is first recorded). Subjects who do not meet response criteria will be censored at the day of their last tumor assessment (from any compartment).
Time frame: Up to 29 months.
Response rate of lymph node evaluated by Lugano 2014.
Subjects will be evaluated for response in lymph node based on Lugano 2014 criteria. Disease status will be evaluated by enhanced computed tomography (CT). The detailed response criteria (CR, PR, PD, SD) is defined in Lugano 2014. Complete response (CR) or partial response (PR) will be regarded as response. Response rate is calculated by Subjects who confirmed response/Total subjects.
Time frame: At the end of each cycle (each cycle is 28 days) until progression up to 29 months;
Response rate of viscera evaluated by Lugano 2014 criteria.
Subjects will be evaluated for response in viscera based on Lugano 2014 criteria. Disease status will be evaluated by enhanced computed tomography (CT). The detailed response criteria (CR, PR, PD, SD) is defined in Lugano 2014. Complete response (CR) or partial response (PR) will be regarded as response. Response rate is calculated by Subjects who confirmed response/Total subjects.
Time frame: At the end of each cycle (each cycle is 28 days) until progression up to 29 months;