Peripheral T-Cell Lymphoma
Conditions
Interventions
Experimental Group:Linperlisib in combination with Azacitidine
Sponsors
The Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
14 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 14-75 years, regardless of gender. 2. ECOG performance status score 0-3, with an estimated survival period >=3 months. 3. Confirmed diagnosis of relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL). 4. Patients deemed suitable for chemotherapy ("fit"), or those unsuitable for intensive chemotherapy or intolerant to chemotherapy. 5. Liver and kidney function within 14 days before enrollment: TBIL<=1.5×ULN, ALT, AST<= 2.0×ULN, Cr <=1.5×ULN; 6. Voluntary participation with signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with severe cardiac insufficiency, defined as cardiac ejection fraction (EF) 3× upper limit of normal (ULN); Pregnant or lactating women, or patients of childbearing potential unwilling to use contraception. 4. Severe renal insufficiency with renal function index (Cr) more than 2 times of the upper limit of normal (ULN); Or 24-hour urinary creatinine clearance Ccr less than 50ml/min; 5. Severe active infection prior to treatment. 6. Clinically significant neurological disorders or severe psychiatric conditions that impair understanding of or compliance with the study protocol. 7. Pregnancy, planned pregnancy, or lactation. 8. Concurrent malignancy requiring active treatment. 9. Patients unable to complete the required treatment plan or follow-up evaluations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Over response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission, CR;Duration of response, DOR;Progression free survive, PFS;Overall survival,OS;Safety; | — |
Countries
China
Contacts
Public ContactHongyun Xing
The Affiliated Hospital of Southwest Medical University
Outcome results
None listed