Peripheral T-cell Lymphoma
Conditions
Interventions
experimental group:PD-1 Antibody combined with Chidamide, Prednisone, Etoposide, and Lenalidomide as introductive treatment following Pegaspargase and Pemetrexed as consolidated therapy.
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) identified histopathologically/cytologically by the 2016 World Health Organization (WHO) Classification of Disease WHO are unable to tolerate or unwilling to undergo intense chemotherapy; 2. Aged 16-70 years; 3. Expected survival time > 3 months; 4. ECOG = 90g/L; (2) ANC >= 1.5 x 10^9/L; (3) PLT >= 75 x 10^9/L; Biochemical examination: (1) TBIL = 50mL/min (Cockcroft-Gault formula) coagulation function (unless subjects are receiving anticoagulant therapy and coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant therapy at screening time) : 1) International standardized ratio (INR) 15mm or extranodal lesions > 10mm) and FDG-PET positive lesions] 7. The woman is not breastfeeding, is not pregnant and agrees not to be pregnant during the study period and for the following 12 months. Male patients agreed that their spouse would not become pregnant during the study period and for 12 months thereafter; 8. Sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Patients combined with hemophagocytic syndrome. 2. Serious systemic infections or local infections during the 2 months before screening. 3. Patients diagnosed as CNS lymphoma. 4. Any prior exposure to PD-1/PD-L1,chidamide, Lenalidomide, Pegaspargase and Pemetrexed agents. 5. Previous allogeneic stem cell transplant or allogeneic organ transplantation. 6. Previous autologous stem cell transplant within 6 months. 7. Previous major surgery and live vaccine injection within 28 days. 8. Has enrolled in any other trials during 3 months prior to screening or concurrently enrolled in any other trials. 9. Uncontrolled internal medicine disease(including uncontrolled diabetes, severe incompetence cardiac, lung, liver and pancreas) 10. Human immunodeficiency virus (HIV)-positive patients. 11. Rejecting adopting reliable contraceptive method in pregnancy or lactation period 12. History of cancer in 5 years before screening., including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved). 13. With no legal capacity,medical or ethical reasons affecting research proceeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival;Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactXue Hongwei
The Affiliated Hospital of Qingdao University
Outcome results
None listed