Peripheral T-cell lymphoma
Conditions
Interventions
Low dose experimental group:40mg/d combination therapy of linprixate and Carolizumab
High dose experimental group:60mg/d combination therapy of linprixate and Carolizumab
Expansion Group:Treatment with maximum tolerable dose of the first stage combined with Carolizumab
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Peripheral T-cell lymphoma patients diagnosed by histology or cytology; 2. R/R PTCL with at least 1 line of treatment in the past; 3. R/R PTCL with measurable lesions (diameter greater than 1.5cm), at least one measurable lesion according to IRWG; 4. Age range from 18 to 75 years old; 5. ECOG = 70x10^12/L; PLT >= 50x10^9/L; NE >= 1x10^9/L; LVEF >= 50%; Glomerular filtration rate >= 60 milliliters per minute; ALT and AST = 3 months; 9. Can swallow and take medication orally; 10. Voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previously used any PI3K- d Isomeric therapy or PD-1 monoclonal antibody; 2. Subjects who received immunomodulatory drugs within 4 weeks prior to screening, including thymosin, interferon, and interleukin; 3. Evidence of active central nervous system lymphoma; 4. History of immunodeficiency (acquired or congenital), or history of organ transplantation, or history of allogeneic bone marrow or hematopoietic stem cell transplantation; 5. The dosage of steroid hormones is greater than 20mg/d and lasts for more than 14 days; 6. Previous malignant tumors (excluding recurrent/refractory peripheral T-cell lymphoma), but excluding malignant tumors that have been cured and have no active lesions within 3 years; 7. Evidence of complications or medical conditions, including but not limited to evidence that may interfere with the study or put patients at serious risk: severe cardiovascular disease (New York Heart Function Classification III-IV, myocardial infarction within 6 months prior to screening, uncontrolled or symptomatic arrhythmia) and/or severe pulmonary disease; 8. HIV infection, active hepatitis B, active hepatitis C. Active infection of hepatitis B and C viruses (volunteers who are HBsAg or HBcAb positive and have HBV-DNA greater than or equal to 1000 coRPies/ml or 200IU/ml; positive for hepatitis C antibodies and hepatitis C virus ribonucleic acid (HCV-RNA); 9. Active and uncontrolled infections that require systemic treatment (such as pneumonia); 10. Pregnant or lactating women; 11. According to the judgment of the researchers, there are accompanying diseases that seriously endanger patient safety or affect the completion of the study, and interfere with the absorption or metabolism of PD-1 monoclonal antibodies or PI3K inhibitors; 12. Continuous use of drugs that interact with PD-1 monoclonal antibodies or PI3K inhibitors is required, or drugs with a half-life of no more than 5 are used before the study; 13. Continuous treatment with potent or moderate CYP3A inhibitors or inducers is required. Participants who have taken CYP3A potent or moderate inhibitors or inducers within 7 days prior to the study drug administration (or have taken these drugs for no more than 5 half-lives) are not eligible for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR (Phase 2);Maximum tolerated dose, MTD (Phase 1); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;Disease control rate, DCR;Duration of Response, DoR;Overall survival, OS;Adverse events (incidence and severity); | — |
Countries
China
Contacts
Public Contactzouliqun
West China Hospital, Sichuan University
Outcome results
None listed