peripheral T-cell lymphoma
Conditions
Interventions
the treatment group :Zimberelimab combined with Chidamide and etoposide/gemcitabine
Sponsors
Beijing Chaoyang Sanhuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Signed of informed consent; 2. Age >= 18 years and = 3 months; 8. The patient must be able to swallow the oral drug without obvious gastrointestinal abnormalities. 9. The main organs have sufficient functions; 10. The investigator assessed that the heart and lung functions were normal; 11. The blood pressure is normal, and the blood pressure of patients with hypertension is well controlled (no higher than 140/90 mmHg); 12. No obvious contraindication of chemotherapy and immunotherapy; 13. Volunteer to take effective contraceptive measures during the study treatment and within 120 days after the treatment; 14. Women of childbearing age must have taken reliable contraceptive measures, and conducted blood pregnancy test within 7 days before enrollment, and the result is negative.
Exclusion criteria
Exclusion criteria: 1. Patients with ALK positive anaplastic large cell lymphoma or angioimmunoblastic T-cell lymphoma; 2. Have received anti PD-1/PD-L1 antibody, anti PD-L2 antibody, CTLA-4 antibody, or other drugs/antibodies acting on T cell co stimulation or checkpoint access in the past; 3. Patients with severe active autoimmune diseases who need glucocorticoid or systemic immunosuppression treatment within 2 years before the first administration. Patients whose diseases have been controlled and do not need systemic immunosuppressive treatment are allowed to be included in the group, such as type I diabetes, hypothyroidism that only needs hormone replacement treatment, and skin diseases that do not need systemic treatment (such as vitiligo, psoriasis, and alopecia); 4. Have congenital or acquired immune deficiency (such as HIV infection), active hepatitis B (HBV-DNA >= 1*104 copies/ml or 2000 IU/ml) or hepatitis C (hepatitis C antibody is positive and HCV RNA is higher than the detection limit of the analytical method); 5. There are infectious diseases within 14 days before the first administration, and systemic anti infection treatment is required; 6. Subjects who need to use corticosteroids (>10 mg/day prednisone or equivalent dose of similar drugs) or other immunosuppressants for systematic treatment within 14 days before the first administration of the study drug or during the study. In the absence of active autoimmune diseases, it is allowed to inhale or locally use steroids, or replace adrenal hormones with a dose 480ms, QTc interval calculated by Fridericia formula) occurred within 6 months before the first administration; 9. Evaluated by the investigator, the patient has undergone major surgery and has not recovered within 28 days before the first administration; 10. Inoculate live vaccine (inactivated vaccine is allowed) within 4 weeks before the first use of the study drug; 11. Participated in other clinical trials within 4 weeks before enrollment; 12. Known hypersensitivity to the study drug or any of its excipients, or severe allergic reaction to other monoclonal antibodies. 13. Pregnant or lactating women; 14. The presence of other serious physical or mental diseases or laboratory examination abnormalities may increase the risk of participating in the study, or affect the compliance of the study, or interfere with the study results and the patients who the investigator considers unsuitable for participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate, DCR;Progression-Free-Survival, PFS;overall survival, OS;Safety; | — |
Countries
China
Contacts
Public ContactPi Jinping
Beijing Chaoyang Sanhuan Cancer Hospital
Outcome results
None listed