Cutaneous T-cell lymphoma
Conditions
Interventions
Total:Oral Chidamide 30mg twice weekly
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18 to 75 years old; 2. Patients with histopathologically confirmed, stage IB-IVA and measurable cutaneous T-cell lymphoma, with or without lymph node involvements; 3. Refractory or relapsed disease (including DOR shorter than 30 days) following at least one systemic therapy (including total skin electron beam therapy, Bexarotene, Retinoic acid, Isotretinoin, IFN, Extracorporeal photopheresis, Methotrexate), patients with lymph node involvements must have been treated by at least one chemotherapy; 4. ECOG performance status 0-2; 5. Weight: male 67+/-20 kg(47-87kg), female 55+/-20kg(35-75kg); 6. Life expectancy >=3 months; 7. Have not been treated by radiotherapy, chemotherapy, target therapy or stem cell transplantation during the 4 weeks before enrollment; 8. Patients who have signed the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Patients have been treated with HDAC inhibitors; 2. Patients with visceral (including bone marrow) involvements; 3. Patients with history of clinically significant QT prolongation (Male >450ms, female >470ms), or ventricular tachycardia (VT), atrial fibrillation (AF), heart block (HB), myocardial infarction (MI) onset within one year, congestive heart failure (CHF), clinically significant coronary artery disease which needs drug treatment; 4. Patients have undergone organ transplantation; 5. Patients have participated during the 30 days before enrollment or are in other new drug clinical trials; 6. Patients with active bleeding or newly diagnosed thromboembolic disease, or patients with hemorrhagic tendency who are using anticoagulants; 7. Patients with active infection; 8. Patients who have been conducted the surgery on a major organ in less than 6 weeks; 9. Hepatic function: Serum total bilirubin > 1.5 X normal range; ALT/AST > 2.5 folds of normal range or 5 folds for liver metastasis; Renal function: Serum creatine > 1.5 folds of normal range; Complete blood count: Absolute neutrophil counts < 1.5*10^9/L,Platelet counts < 80*10^9/L, Hemoglobin <90g/L; 10. Patients with mental disorders, or otherwise unable to provide informed consent; 11. History of drug abuse or alcoholism; 12. Pregnant or lactating women and patients in child-bearing age who will not carry out birth control; 13. Patients considered by investigators not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to response;Relief of pruritus;Duration of response;Progression free survival; | — |
Countries
China
Contacts
Public ContactYuankai Shi
Outcome results
None listed