Refractory/Recurrent Peripherral T-cell Lymphoma
Conditions
Interventions
Test group:Chidamide combined with Duvillisib
Sponsors
The First Aiffiliated hosptical of xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Peripheral T-cell lymphoma (PTCL) or NK/T-cell lymphoma confirmed by histopathology/cytology according to the classification standard of the World Health Organization in 2008 2.Relapsed and refractory patients who have received at least first-line systemic treatment with anthracycline-containing drugs in the past.Recurrence is defined as relapse after CR or progression after PR,SD. Refractory disease was defined as previous systemic chemotherapy, PD in response evaluation for 2 cycles, or SD in response evaluation for 4 cycles. 3.There must be at least one evaluable or measurable lesion meeting Lugano2014 standard: lymph node lesion, and the measurable lymph node length should be > 1.5cm; 4. patients aged at 18-75 years old; 5.ECOG 0-2 6.Routine blood examination: absolute neutrophil count = 1.5× 10 9/L, platelet = 75x10 9/L, HB = 80g/L. 7.Expected survival =3 months 8.No radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation was received within 4 weeks before enrollment. 9.The patient or his/her legal representative must provide written informed consent before carrying out any special inspection or procedure of the study.
Exclusion criteria
Exclusion criteria: 1.patients with central nervous system (CNS) or meningeal invasion 2..Any of the following laboratory abnormalities: absolute neutrophil count (ANC) 1.5 upper limit of normal value (ULN), or AST or ALT >2.5ULN, except the following situations. if patients with liver infiltrated by lymphoma cells, AST and ALT 1.5ULN or partially activated prothrombin time (APTT) > 1.5 ULN 4.The active infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) should be excluded except for the following patients: patients with HBV infection (HBsAg or HBcAg positive) but HBV DNA negative. These patients need continuous antiviral treatment and HBV DNA PCR detection every cycle. additionally, patients with HCV serology positive but HCV RNA negative can be enrolled. 5.In patients with CMV infection (IgM positive), CMV DNA was positive by PCR. 6.Meet any of the following criteria related to visceral function: all kinds of clinically significant abnormal rhythm or conduction need clinical pre-diagnosis Hereditary QT interval syndrome or QTcF>480 msec or taking drugs that may cause Qt interval delay or torsade de pointes. A variety of clinically significant cardiovascular diseases, including acute myocardial infarction, unstable angina and coronary artery bypass grafting in the first 6 months of the group, with new york's cardiology (NYHA) classification of grade 3 or above. Left ventricular ejection fraction (LVEF ) 160 mmHg or diastolic blood pressure > 100 mgHg). 7.Have a history of stroke or intracranial hemorrhage within 6 months before drug administration for the first time 8.Major surgery was performed within 4 weeks before drug administration for the first study 9.Any PI3K inhibitor has been used before and the disease has progressed during the treatment period (within 6 months after the last use) 10.Received systemic anti-tumor therapy or radiotherapy within 4 weeks before the first study drug administration 11.The last time you participated in clinical trials of other drugs before the administration of the first study drug was less than 2 weeks or the last time you used targeted drugs (such as antibody drugs) was less than 4 weeks 12. patients received the transplantation of somatic hematopoietic stem cells within 3 months before first drug administration 13.patients received allogeneic hematopoietic stem cell transplantation or having any active graft-versus-host disease within 6 months before first drug administration. 14.Take a strong inducer or inhibitor of cytochrome P4503A4 (CYP3A4) within 2 weeks before drug administration (3 weeks for Hypericum perforatum) for the first time. 15.Before the first enrollment, the toxic reaction of previous anti-tumor therapy has not recovered to =1 level (except alopecia). 16.patients with uncontrolled systemic infection requiring intravenous antibiotic treatment 17.Currently suffering from other primary tumors that need active treatment according to the guidelines 18.Inability to take drugs orally, previous surgical history or serious gastrointestinal diseases such as dysphagia and active gastric ulcer may affect the absorption of drugs 19. pregnant (serum pregnancy test results are positive) or lactating women 20.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall respose;complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Partial remission rate;Progress free survival;Overall survival ; | — |
Countries
China
Contacts
Public ContactBing Xu
The First Aiffiliated hosptical of xiamen University
Outcome results
None listed