A Study to Evaluate the Efficacy and Safety of KW-0761 in Chinese Subjects With Mycosis Fungoides… (NCT06285370) | Clinical Trial Compass
Active — Not RecruitingPhase 4
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
China23 participantsStarted 2023-05-29
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Male and female Chinese subjects ≥18 years of age at the time that written informed consent is obtained.
. Histologically confirmed diagnosis of MF or SS;
. Stage IB, IIA, IIB, III, and IV.
. 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.
. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1.
. 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.
. Adequate hematological function:
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Response Rate
Timeframe: At the end of each cycle (each cycle is 28 days) until progression up to 29 months;
. 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.
. 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.
. Clinical evidence of central nervous system metastasis.
. Psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit compliance with study requirements.
. Significant uncontrolled intercurrent illness including, but not limited to:
. Known or tests positive for human immunodeficiency virus (HIV) or history of HIV infection, or hepatitis C disease or history of hepatitis C infection.
. 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);
. 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.