?Relapsed/Refractory Cutaneous T-Cell Lymphoma (CTCL)
Conditions
Interventions
Observation group:NA
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1?.Age = 18 years old and < =70 years old.?; 2. Patients diagnosed with CD30+ CTCL, IIB-IVB stage recurrent/refractory MF or Sézary syndrome, IIB stage patients must meet the following conditions simultaneously: (1) Extensive/multicentric tumor involvement; (2) Local radiotherapy ineffective, or recurrence after radiotherapy, or tumor location unsuitable for local radiotherapy (e.g., facial involvement). Diagnostic and staging criteria for IIB-IVB stage MF or Sézary syndrome are detailed in Appendix I. Patients must have initiated treatment with BV, Chidamide, MIT-LIP, or Golidocitinib regimens prior to enrollment, and the treatment duration must not exceed 28 days from initiation. 3.Recurrent/Refractory Patients?: Patients who have received ?=3 cycles of anti-tumor therapy? and exhibit ?no response, disease progression, or recurrence?. 4.ECOG Performance Status Score =2? (ECOG Performance Status Score is detailed in Appendix II). 5?.Translation?: The clinical laboratory test values within 4 days prior to the first dose of the investigational drug must meet the following criteria: ?Total bilirubin? must be =1.5× the upper limit of normal (ULN). If elevated bilirubin levels can be reasonably attributed to lymphoma involvement of the liver, total bilirubin may be allowed up to =3×ULN. ?Alanine aminotransferase (ALT)? or ?aspartate aminotransferase (AST)? must be =2.5×ULN. If elevated ALT/AST levels can be reasonably attributed to lymphoma involvement of the liver, both ALT and AST must be =5×ULN. ?Serum creatinine? must be =3×ULN and/or ?creatinine clearance? (or calculated creatinine clearance) must be =30 mL/min/1.73m² (using the Cockcroft-Gault formula). 6.The patient must have a disease that is ?radiologically measurable or clinically assessable?. 7.From the time of signing the informed consent form until 6 months after the last dose of the study drug, women of childbearing potential must agree to use effective contraception (confirmed by the investigator) during this period, and the urine pregnancy test result at enrollment must be negative; 8.For patients with a uterus and ovaries who meet the following criteria: If they have reproductive potential, they must agree to use ?two effective contraceptive methods simultaneously? from the time of signing the informed consent form until 6 months after the last dose of the study drug, or agree to ?complete abstinence? (if this aligns with the patient's preferred and habitual lifestyle), or have been ?postmenopausal for at least 1 year prior to the screening visit?, or have undergone ?surgical sterilization?. ?Unacceptable contraceptive methods? include periodic abstinence (e.g., calendar method, ovulation method, symptothermal method, safe period method), coitus interruptus, use of spermicides alone, and lactational amenorrhea method. ?Female and male condoms must not be used simultaneously?.
Exclusion criteria
Exclusion criteria: 1.Patients who are ?breastfeeding?, or have a ?positive serum pregnancy test during screening?, or a ?positive urine pregnancy test prior to the first dose of study drug on Day 1?. 2.Researchers believe that any serious medical or psychiatric condition that may interfere with completing the treatment according to this study protocol exists. 3.Simultaneously diagnosed with other non-Hodgkin lymphoma; 4.Allergic to recombinant proteins, mouse proteins, or any excipients in drug formulations. ?; 5.Diseases unrelated to cancer that are life-threatening?; 6?.Severe diseases of the central nervous system (CNS), lungs, kidneys, or liver that are unrelated to the patient's cancer; 7.Known to have active brain/meningeal diseases, including signs or symptoms of progressive multifocal leukoencephalopathy (PML). 8.Known to be positive for human immunodeficiency virus (HIV); 9.Known as active hepatitis B or active hepatitis C infection; 10.Within 1 week prior to the first dose of the investigational drug, any severe active systemic viral, bacterial, or fungal infection requiring systemic antimicrobial therapy is excluded. Oral antibiotic prophylaxis is permitted. 11.Within 6 months prior to the first dose of the investigational drug, the presence of any of the following cardiovascular conditions or abnormal findings: myocardial infarction within 6 months prior to enrollment; NYHA Class III or IV heart failure; evidence of uncontrolled cardiovascular disease, including arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. 12?Another primary malignant tumor (with a history of at least 3 years without remission). The following conditions are exempt from the 3-year restriction: completely resected carcinoma in situ, such as non-melanoma skin cancer shown by biopsy and cervical carcinoma in situ or squamous intraepithelial lesions indicated by Pap smear; 13.History of pancreatitis or significant risk factors for developing pancreatitis (e.g., previous pancreatitis, uncontrolled hyperlipidemia, excessive alcohol consumption, uncontrolled diabetes, biliary disease, and medications known to increase triglyceride levels or cause pancreatic toxicity). 14.Any other circumstances that the researcher or clinical investigator considers may interfere with the patient's ability to receive or complete the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate after four treatment cycles; | — |
Secondary
| Measure | Time frame |
|---|---|
| QoL;DCR;DoR,;Objective response rate; | — |
Countries
China
Contacts
Public ContactWu Wenyu, Chen Tong
Huashan Hospital, Fudan University
Outcome results
None listed