Peripheral T-Cell Lymphoma
Conditions
Interventions
Experimental group:PI3K inhibitor combined with BV-CDP regimen (brentuximab vedotin, chidamide, decitabine, sintilimab (PD-1)) treatment
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Peripheral T-cell lymphoma (PTCL) confirmed by histopathology/cytology, according to the World Health Organization 2008 classification standard; 2. Relapsed/refractory patients who have previously received at least one line of systemic therapy containing an anthracycline. Relapse is defined as patients who relapsed after achieving CR or progressed after PR; refractory is defined as patients whose response evaluation after 2 cycles of prior systemic chemotherapy was PD, or after 4 cycles was SD; 3. Must have at least one evaluable or measurable lesion according to Lugano 2014 criteria: for lymph node lesions, the measurable longest diameter should be >1.5 cm; for non-lymph node lesions, the measurable longest diameter of extranodal lesions should be >1.0 cm; 4. Age 18-65 years, any gender; 5. ECOG performance status 0-2; 6. Blood routine examination: absolute neutrophil count >=1.5×10^9/L, platelets >=75×10^9/L, Hb >=80 g/L; 7. Expected survival >=3 months; 8. No radiotherapy, chemotherapy, targeted therapy, or hematopoietic stem cell transplantation within 4 weeks before enrollment; 9. The patient or their legally authorized representative must provide written informed consent before any study-specific examinations or procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with lymphoma involving the central nervous system (CNS) or meninges; 2. Any of the following laboratory abnormalities: absolute neutrophil count (ANC) 1.5 times the upper limit of normal (ULN), or AST or ALT >2.5 ULN, except in the following cases: (1) Patients with Gilbert’s disease with TBiL and direct bilirubin (DBiL) >2.5 ULN and normal AST and ALT can be enrolled; (2) Patients with lymphoma liver infiltration and AST and ALT >5 ULN can be enrolled; (3) Estimated glomerular filtration rate (eGFR) 1.5 ULN or activated partial thromboplastin time (aPTT) >1.5 ULN; serum amylase or lipase >1 ULN; 4. Patients with known active infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), except the following: patients with HBV infection [hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive] but HBV-DNA negative can be enrolled; these patients need continuous antiviral therapy after enrollment and HBV-DNA PCR testing every cycle; patients who are HCV seropositive but HCV-RNA negative can be enrolled; 5. Patients with concurrent cytomegalovirus (CMV) infection (IgM positive) and positive CMV-DNA PCR test; 6. Meets any of the following heart function-related criteria: (1) Any clinically significant arrhythmia or conduction disorder requiring medical intervention; (2) Hereditary long QT syndrome or QTcF > 480 msec, or currently taking drugs that may cause QT prolongation or torsades de pointes arrhythmia; (3) Any clinically significant cardiovascular disease, including acute myocardial infarction, unstable angina, coronary artery bypass surgery within 6 months before enrollment, congestive heart failure of NYHA class 3 or higher, left ventricular ejection fraction (LVEF) 160 mmHg or diastolic pressure > 100 mmHg), etc.; 7. History of stroke or intracranial hemorrhage within 6 months before the first administration of the study drug; 8. Major surgery within 4 weeks before the first administration of the study drug; 9. Prior use of any PI3K inhibitor with disease progression during treatment (within 6 months after last dose); 10. Systemic anti-tumor therapy or radiotherapy within 4 weeks before the first administration of the study drug; 11. Participation in another drug clinical trial prior to first administration of the study drug, with the last dose of small molecule drugs less than 2 weeks ago or large molecule drugs (such as antibody drugs) less than 4 weeks ago; 12. Autologous hematopoietic stem cell transplantation within 3 months before the first administration of the study drug; 13. Allogeneic hematopoietic stem cell transplantation within 6 months before the first administration of the study drug or evidence of any active graft-versus-host disease; 14. Toxic reactions from prior anti-tumor therapy have not recovered to = grade 1 (excluding alopecia) prior to the first administration of the study drug; 15. Concomitant uncontrolled systemic infections requiring intravenous antibiotic treatment; 16. Currently having other primary tumors that require active treatment according to guidelines; 17. Inability to take oral medication due to previous surgery or severe gastrointestinal disease such as difficulty swa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) after 2 cycles of chemotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate (CR) and partial response rate (PR) after 2 cycles of chemotherapy;1-year progression-free survival (PFS);1-year overall survival (OS); | — |
Countries
Cnina
Contacts
Public ContactLiping Dou
Chinese PLA General Hospital
Outcome results
None listed