Cutaneous T-cell lymphoma (CTCL)
Conditions
Interventions
Treatment group:Zeprumetostat
Sponsors
Shandong First Medical University Affiliated Dermatology Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients are eligible for enrollment if they voluntarily agree to participate in the study and sign the written informed consent form; 2.are aged >=18 years, regardless of sex; 3.patients have histopathologically confirmed cutaneous T-cell lymphoma (CTCL) and meet all of the following criteria: 1) early-stage CTCL, including stage IB or IIA, or advanced-stage CTCL, including stage IIB, IIIA, IIIB, IVA, or IVB; 2) prior receipt of at least one systemic therapy, including but not limited to phototherapy, bexarotene, retinoids, interferon, methotrexate, chidamide, or brentuximab vedotin, with failure to achieve remission or subsequent disease relapse; and 3) a modified Severity-Weighted Assessment Tool (mSWAT) score >=10; 4.patients have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2; 5.patients have no central nervous system involvement; 6.patients have adequate organ function at screening, defined as follows: 1) bone marrow function: white blood cell count >=2 × 10^9/L, platelet count >=75 × 10^9/L, and hemoglobin>=80 g/L; 2) hepatic function: aspartate aminotransferase and alanine aminotransferase =40 mL/min; 7.any adverse events and/or complications caused by prior therapies have resolved to Grade 2 or lower; 8.female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to use effective contraception during treatment with the study drug and for 3 months after the last dose; 9.patients have an estimated life expectancy of >=24 months; 10.patients are able to receive treatment and undergo follow-up according to the study schedule.
Exclusion criteria
Exclusion criteria: 1.Patients aged <18 years; 2.Known hypersensitivity to any component; 3.History of any malignancy other than CTCL within 5 years prior to screening, except for cured cutaneous squamous cell carcinoma, basal cell carcinoma, or cervical carcinoma in situ; 4.History of moderate to severe congestive heart failure within 3 months prior to screening, defined as New York Heart Association (NYHA) functional class III or higher, or a history of cardiovascular or cerebrovascular events or severe bleeding events, which in the investigator’s judgment renders the patient unsuitable for participation in this clinical study; 5.Presence of severe infection prior to screening, such as severe infection requiring hospitalization or systemic intravenous anti-infective therapy, or severe opportunistic infection; or any other history of infection that, in the investigator’s judgment, may be exacerbated by participation in this study; 6.Presence of moderate to severe hepatic or renal impairment prior to screening, such as active hepatitis, decompensated liver cirrhosis, severe biliary tract disease, or other clinically significant hepatic or renal disorders; 7.Presence at screening of severe, progressive, or uncontrolled underlying medical conditions involving the gastrointestinal, hematopoietic, endocrine, neurological, or psychiatric systems, including depression, suicidal ideation, or psychological disorders, that may affect administration of the study drug or compliance with the protocol; 8.Presence at screening of CTCL requiring urgent systemic therapy, rapidly progressive CTCL, or life-threatening CTCL; 9.Bone marrow function at screening does not meet the inclusion criteria; 10.Prior treatment with an EZH1 or EZH2 inhibitor; 11.Prior stem cell transplantation; 12.Female patients who are pregnant or breastfeeding; 13.Inability to avoid the use of strong or moderate CYP3A4/5 inhibitors, strong CYP3A4/5 inducers, proton pump inhibitors, or other relevant concomitant medications during the study period; 14.Participation in another clinical trial within 3 months prior to enrollment; 15.Patients deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Numeric Rating Scale;Time to response;Safety and tolerability;Dermatology Life Quality Index;Time to response;Time to next treatment;Overall response rate;Progression-free survival;Duration of response;Progression-free survival;Duration of response; | — |
Countries
China
Contacts
Public ContactZhang Furen
Shandong First Medical University Affiliated Dermatology Hospital
Outcome results
None listed