Trial Title:
A Study to Evaluate the Efficacy and Safety of KW-0761 in Chinese Subjects With Mycosis Fungoides or Sézary Syndrome Previously Treated With Systemic Therapy
NCT ID:
NCT06285370
Condition:
Cutaneous T-Cell Lymphoma
Conditions: Official terms:
Mycoses
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Mogamulizumab
Conditions: Keywords:
mycosis fungoides/sézary syndrome
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This is an open-label, multicenter, single arm study.
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
No Masking
Intervention:
Intervention type:
Drug
Intervention name:
Mogamulizumab
Description:
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.
Arm group label:
KW-0761
Summary:
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
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily signed and dated ethics committee (EC) approved informed consent form in
accordance with regulatory and institutional guidelines. Written informed consent
must be obtained prior to performing any study-related procedure.
2. Male and female Chinese subjects ≥18 years of age at the time that written informed
consent is obtained.
3. Histologically confirmed diagnosis of MF or SS;
4. Stage IB, IIA, IIB, III, and IV.
5. Patients who have failed at least one prior systemic therapy. Systemic therapy
includes, for example, interferon, denileukin diftitox, retinoid, photopheresis,
anti-neoplastic chemotherapy, methotrexate, and Histone deacetylase (HDAC)
inhibitor.
- Ultraviolet light therapy (Psoralen plus ultraviolet A [PUVA], ultraviolet B
[UVB] etc), systemic steroid monotherapy, topical steroid or other topical
agents, and any radiation are not considered to be a systemic therapy.
6. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1.
7. The subject has resolution of all clinically significant toxic effects of prior
cancer therapy to Grade ≤ 1 by the National Cancer Institute Common Terminology
Criteria for Adverse Events, version 5.0 (NCI-CTCAE, ver. 5.0) excluding the
specifications required in 8, 9, and 10 below.
8. Adequate hematological function:
- absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
- platelets ≥ 100.0 × 10^9/L;
- in subjects with known bone marrow involvement, ANC must be ≥ 1.0 × 10^9/L and
platelets ≥ 75.0 × 10^9/L.
9. Adequate hepatic function:
- Total bilirubin ≤ 1.5 times the specific institutional upper limit of normal
(ULN);
- aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 × ULN or
≤ 5.0 × ULN in the presence of known hepatic involvement by CTCL.
10. Adequate renal function:
- serum creatinine (SCr) ≤ 1.5 × ULN, or calculated creatinine clearance (CCr)>
50 mL/min using the Cockcroft-Gault formula.
(CCr={((140-age) × body weight)/(72 × SCr)} × 0.85 (if female))
11. Patients with MF and a known history of non-complicated staphylococcus
infection/colonization are eligible provided they continue to receive stable doses
of prophylactic antibiotics.
12. Women of childbearing potential must have a negative pregnancy test within 7 days
prior to receiving study medication.
13. Women of childbearing potential (WOCBP)* and fertile men who consent to practice
contraception using highly effective methods during a period from the day providing
her consent to the end of the study (for women) or from the start of IP
administration to the end of the study (for men). WOCBP shall have a negative
pregnancy test result in the screening examination and a negative pregnancy test
result in the pre-dose examination at Day 1.
- WOCBP do not include women who underwent permanent contraception,
postmenopausal women (in the case of the absence of menstruation for 12 months
or more regardless of other medical reasons and serum follicle stimulating
hormone (FSH) level >40 mIU/mL) and women who are anatomically incapable of
becoming pregnant.
Exclusion Criteria:
1. Current evidence of large cell transformation (LCT). Patients with clinical features
suggestive of LCT are recommended to have a biopsy performed within 4 months prior
to Cycle 1 Day 1 to rule out transformed disease. Patients with a history of LCT but
without current aggressive disease and no current evidence of LCT on pathology in
skin or lymph nodes are eligible.
2. Diagnosed with a malignancy other than MF/SS in the past 2 years from the time that
written informed consent is obtained. However, subjects with non-melanoma skin
cancers, melanoma in situ, localized cancer of the prostate with current
prostate-specific antigen of < 0.1 ng/mL, treated thyroid cancer or cervical
carcinoma in situ, or ductal/lobular carcinoma in situ of the breast within the past
2 years may be enrolled as long as there is no current evidence of disease.
3. Clinical evidence of central nervous system metastasis.
4. Psychiatric illness, disability or social situation that would compromise the
subject's safety or ability to provide consent, or limit compliance with study
requirements.
5. Significant uncontrolled intercurrent illness including, but not limited to:
- uncontrolled infection requiring antibiotics;
- clinically significant cardiac disease (Class III or IV of the New York Heart
Association [NYHA] classification);
- unstable angina pectoris;
- angioplasty, stenting, or myocardial infarction within 6 months;
- uncontrolled hypertension (systolic blood pressure [BP] > 160 mmHg or diastolic
BP>100 mmHg, found on 2 consecutive measurements separated by a 1-week period)
despite 2 antihypertensive medications;
- clinically significant cardiac arrhythmia;
- uncontrolled diabetes.
6. Known or tests positive for human immunodeficiency virus (HIV) or history of HIV
infection, or hepatitis C disease or history of hepatitis C infection.
7. Tests positive for hepatitis B virus surface (HBs) antigen or both HBc antibody and
hepatitis B virus (HBV)-DNA positive (over the lower limit of quantification);
- Patients with HBs antibody positive due to a hepatitis B vaccine will be
allowed to participate in this trial.
8. Active herpes simplex or herpes zoster. Patients on prophylaxis for herpes who
started taking medication at least 30 days prior to the pretreatment visit, have no
signs of active infection, and whose last active infection was more than 6 months
ago may enter the study, and should continue to take the prescribed medication for
the duration of the study.
9. Experienced allergic reactions to monoclonal antibodies or other therapeutic
proteins.
10. Known active autoimmune disease (e.g., Graves' disease; systemic lupus
erythematosus; rheumatoid arthritis; Crohn's disease; psoriasis).
11. Is pregnant (confirmed by beta human chorionic gonadotrophin [β-HCG]) or lactating.
12. Prior treatment with mogamulizumab.
13. Have had any therapy directed against the subject's underlying cancer or any
investigational medications within 4 weeks of registration (skin directed
treatments, including topicals and radiation within 2 weeks of registration
treatment).
14. Subjects on a stable dose of a low dose systemic corticosteroid (≤ 20 mg prednisone
equivalent) for at least 4 weeks prior to the registration may continue use although
the investigator should attempt to taper the use to the lowest dosage tolerable
while on study.
15. Subjects on a stable dose of medium or low potency topical corticosteroids for at
least 4 weeks prior to the registration may continue use at the same dose, although
the investigator should attempt to taper the use to the lowest dosage tolerable
while on study.
16. History of allogeneic transplant.
17. Autologous hematopoietic stem cell transplant within 90 days of the screening.
18. Patients on any immunomodulatory drug for concomitant or intercurrent conditions or
who have received any of these agents within 4 weeks of registration, including but
not limited to the following, will be excluded: low-dose or oral methotrexate,
azathioprine, iv immunoglobulin, low-dose or oral cyclophosphamide, cyclosporine,
mycophenolate, infliximab, etanercept, leflunomide, adalimumab, lenalidomide,
abatacept, rituximab, anakinra, interferon-β, interleukin-2, and natalizumab.
19. Anyone otherwise considered unsuitable participation in the study by the
investigator or subinvestigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yuankai Shi
Phone:
13701251865
Email:
syuankai@cicams.an.cn
Investigator:
Last name:
Yuankai Shi
Email:
Principal Investigator
Facility:
Name:
Peking University First Hospital, Department of Dermatology and Venereology
Address:
City:
Beijing
Zip:
100034
Country:
China
Status:
Recruiting
Contact:
Last name:
Ping Tu
Phone:
13021262219
Email:
tup0207@sina.com
Investigator:
Last name:
Ping Tu
Email:
Principal Investigator
Facility:
Name:
Sun Yat-sen University Cancer Center, Department of Medical Oncology
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Huiqiang Huang
Phone:
13808885154
Email:
huang_sysu@163.com
Investigator:
Last name:
Huiqiang Huang
Email:
Principal Investigator
Facility:
Name:
The 2nd Affiliated Hospital of Harbin Medical University
Address:
City:
Harbin
Zip:
150001
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yuzhen Li
Phone:
13936367628
Email:
liyuzhenchina@126.com
Investigator:
Last name:
Yuzhen Li
Email:
Principal Investigator
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Liling Zhang
Phone:
15871725926
Email:
lily1228@sina.com
Investigator:
Last name:
Liling Zhang
Email:
Principal Investigator
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410031
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hui Zhou
Phone:
13975879796
Email:
zhouhui9403@126.com
Investigator:
Last name:
Hui Zhou
Email:
Principal Investigator
Facility:
Name:
The Affiliated Hospital of Inner Mongolia Medical University
Address:
City:
Hohhot
Zip:
010000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Da Gao
Phone:
13947130473
Email:
gaoda72@163.com
Investigator:
Last name:
Da Gao
Email:
Principal Investigator
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110002
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xinghua Gao
Phone:
13940152467
Email:
gaobarry@hotmail.com
Investigator:
Last name:
Xinghua Gao
Email:
Principal Investigator
Facility:
Name:
Zhongshan Hospital Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Peng Liu
Phone:
1581725926
Email:
liu.peng@zshospital.sh.cn
Investigator:
Last name:
Peng Liu
Email:
Principal Investigator
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610044
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Lin Wang
Phone:
18980601701
Email:
LKZWL@126.com
Investigator:
Last name:
Lin Wang
Email:
Principal Investigator
Investigator:
Last name:
Liqun Zou
Email:
Principal Investigator
Facility:
Name:
ZheJiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310005
Country:
China
Status:
Recruiting
Contact:
Last name:
Haiyan Yang
Phone:
18960860662
Email:
yanghaiyantb@126.com
Investigator:
Last name:
Haiyan Yang
Email:
Principal Investigator
Facility:
Name:
First Affiliated Hospital of Zhengzhou University
Address:
City:
Henan
Zip:
450052
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xinhua Wang
Phone:
15036115299
Email:
xinwang512@163.com
Investigator:
Last name:
Xinhua Wang
Email:
Principal Investigator
Start date:
May 29, 2023
Completion date:
January 31, 2026
Lead sponsor:
Agency:
Kyowa Kirin China Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Kyowa Kirin Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06285370
