Peripheral T cell lymphoma
Conditions
Interventions
Intervention group:chidamide monotherapy
control group:N/A
Sponsors
Harbin Institute of Hematology & Oncology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histo-pathologically diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2016 PTCL diagnostic criteria, including PTCL-NOS,angioimmunoblastic T cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL), enteropathy associated T cell lymphoma (EATL) and other subtypes of PTCL(extranodal NK/T cell lymphoma excluded). Primary PTCL patient (except ALK+ ALCL), having finished 6 cycles of 1st line regimen (including various 1st line induction therapy, targeted therapy, and other combined regimens; chidamide-contained or not contained) and achieved complete remission (CR) , not available for autologous stem cell transplantation or do not consider autologous stem cell transplantation. Being able to start the treatment plan of this trial within 12 weeks after the 1st day of the last cycle of their 1st line treatment. 2. Aged >= 18 years, male or female; 3. ECOG 0-3 points; 4. Organ functions should satisfy: renal function, creatinin = 50%, no symptomatic arrythmia; 5. Neutrophil>=1.5×10^9/L, ???>= 80×10^9/L, hemoglobin>= 90g/L; 6. Life expectance>= 3 months; 7. Willing to sign the written consent.
Exclusion criteria
Exclusion criteria: 1. Women during pregnancy or lactation, or fertile women who are not willing to take contraceptive measures; 2. Clinically significant QTc elongation (male>450msfemale>470ms), ventricular tachycardia, atrial fibrillation, cardiac conduction block, history of myocardial infraction within 1 year before enrollment, congestive heart failure, symptomatic coronary heart disease requiring medical treatment; 3. History of organ transplantation; 4. Received symptomatic treatment to marrow cytotoxicity within 7 days prior to enrollment; 5. With active hemorrhage; 6. History of embolism, thrombosis, cerebral hemorrhage, cerebral infraction; 7. With active infection, or continuous fever within 14 days prior to enrollment; 8. History of surgery of visceral organs within 6 weeks prior to enrollment; 9. Liver function, total bilirubin>1.5 times of normal maximum, AST /ALT>2.5 times of normal maximum, or AST/ALT>5 times of normal maximum in patients with liver involvement; renal function, creatinin>1.5 times of normal maximum; 10. With mental disorders, or those who could not sign the written consent; 11. With drug abuse or alcoholic patients that may influence result of the trial; 12. With central nervous system infiltration by lymphoma; 13. Other conditions that the investigators think are not fit for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event free survival;overall survival; | — |
Countries
China
Contacts
Public ContactJun Ma
Harbin Institute of Hematology & Oncology
Outcome results
None listed