Primary cutaneous T-cell lymphoma
Conditions
Interventions
Experimental group:If a PR or better response (VGPR or CR) was achieved after 3 cycles of BV+Chidamide, then 5 additional cycles of BV+Chidamide were given for a total of 8 cycles. Patients were exclu
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old, 40% BSA area or special pathological types such as large cell transformation (LCT) and/or folliculotropic MF (FMF) 24,25; (2) progression after at least 3 months of SDT treatment or no response after 6 months of treatment 26; (3) progression after at least 3 months of conventional first-line therapy, such as interferon, methotrexate, or systemic retinoids, or no response after 6 months or intolerance because of drug-related toxicity.27 Patients with stage IIB disease were required to meet the following criteria: (1) extensive/multicentric tumor involvement; (2) patients who failed to respond to local radiotherapy, or relapsed after radiotherapy, or whose tumor location was not suitable for local radiotherapy (such as facial involvement). The criteria for the diagnosis and staging of stage IIA-IVB MF or Sezary syndrome are provided in Appendix I. 3. Patients had received at least one previous systemic therapy for their disease before enrollment; 4.ECOG performance status score =30 mL/min/1.73m^2. (Cockcroft-Gault formula). 6. Patients must have radiographic or clinically measurable or evaluable lesions; 7. Women of childbearing age had to consent to use a highly effective contraceptive (confirmed by the investigator) from the time of informed consent until 6 months after the last dose of the study drug and had to have a negative urine strip pregnancy test at enrollment. 8. Patients with uterus and ovaries who meet the following conditions: If they were fertile, they agreed to use two effective contraceptive methods together from the time they provided informed consent until 6 months after the last dose of the study drug or to be completely abstinent (if this approach was consistent with the patient's preferred and usual lifestyle) or to have been menopausal for at least 1 year before the screening visit or to have undergone surgical sterilization. (Periodic abstinence (e.g., calendar, ovulatory, symptomatic temperature, safe period), in vitro ejaculation, spermicides only, and lactation amenorrhea are unacceptable contraceptive methods. Female and male condoms must not be used together. Patients with testes, even if they had been surgically sterilized (i.e., in a postvasectomized state), agreed to use effective barrier contraception for the entire duration of study treatment and for 6 months after the last dose of study drug or to agree to complete sexual abstinence if it was consistent with the patient's preferred and usual lifestyle. (Periodic abstinence (e.g., calendar, ovulator
Exclusion criteria
Exclusion criteria: 1. Patients with CD30+MF or Sezary syndrome who had received any of brentuximab vedotin or chidamide before enrollment; 2. Lactating patients, or patients with a positive serum pregnancy test during screening, or a positive urine pregnancy test before the first dose of study drug on day 1; 3. The presence of any serious medical or psychiatric illness considered by the investigator to be likely to interfere with the completion of treatment under the protocol; 4. Concurrent diagnosis of other non-Hodgkin lymphoma; 5. Known allergy to the recombinant protein, mouse protein or any excipients contained in the drug product; 6. Life-threatening diseases unrelated to cancer; 7. Severe central nervous system (CNS), lung, kidney, or liver disease unrelated to the patient's cancer; 8. Known active brain/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML). 9. Known human immunodeficiency virus (HIV) -positive; 10. Known active hepatitis B or hepatitis C infection; 11. Any severe active systemic viral, bacterial, or fungal infection requiring systemic antimicrobial therapy within 1 week before the first dose of study drug. Oral antibiotic prophylaxis was allowed; 12. Antibody-directed or immunoglobulin-based immunotherapy (e.g., immunoglobulin replacement, other monoclonal antibody therapy) within 12 weeks before the first dose of study drug; 13. The presence of any of the following cardiovascular diseases or measurements within 6 months before the first dose of study drug: myocardial infarction within 6 months before enrollment; New York Heart Association (NYHA) class III or IV heart failure; Evidence of current uncontrolled cardiovascular disease, including arrhythmia, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; 14. History of another primary malignancy with no response for at least 3 years. Exempt from the 3-year limit are completely resected cancers in situ, such as non-melanoma skin cancer on biopsy and cervical carcinoma in situ or squamous intraepithelial lesions on Pap smear; 15. A history of pancreatitis or significant risk factors for pancreatitis (e.g., previous pancreatitis, uncontrolled hyperlipidemia, excessive alcohol use, uncontrolled diabetes mellitus, biliary tract disease, and medications known to increase triglyceride levels or cause pancreatic toxicity); 16. Any other condition that the investigator or the project clinician considered to interfere with the patient's acceptance or completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rates lasting at least 4 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Objective response rate;Time to response;Duration of relief;Progress time;The next treatment time;Progression-free survival;Quality of life;Safety;Overall survival ;Disease-specific survival; | — |
Countries
China
Contacts
Public ContactWang Qian
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed