Aim of this study will evaluate the Efficacy and Safety of Anti-PD-1 monoclonal antibody Combined Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma Patients.
Pathological immunohistochemistry or flow cytometry confirmed that R/R PTCL with measurable (diameter greater than 1.5cm) lesions meets any of the following conditions: 1> After 4 courses of standard first-line therapy or 2 courses of more than two-line therapy, the lesions were reduced by <50%; 2> PTCL with disease progression after first-line or induction therapy; 3> After hematopoietic stem cell transplantation, new lesions appear or the size of previously affected lesions increased by more than 50%.
Age ≥ 18 years.
ECOG≤2分.
The main organ functions need to meet the following conditions:Hemogram needs to meet HB ≥70*1012/L，PLT≥50*109/L，NE≥1*109/L；LVEF≥50%;CR≤132umol/l or CCr≥60 ml/min;ALT and AST≤2 times normal range；Lung function≤Level 1;dyspnea(CTCAE v5.0),and blood oxygen saturation without oxygen absorption> 91%.
Accepted major surgery within 4 weeks before treatment.
Prior malignancy (other than Relapsed/Refractory Peripheral T-cell Lymphoma), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin cancer,malignant tonsilloma or carcinoma in situ;
Patients who have previously received failed allogeneic hematopoietic stem cell transplantation.
Have stroke or intracranial hemorrhage within 3 months.
Single group
Anti-PD-1 monoclonal antibody
DrugAnti-PD-1 monoclonal antibody, 200mg i.v d1 (/21d)
Lenalidomide
DrugLenalidomide 25mg qd po d1-d10 (/21d)
Azacitidine
DrugAzacitidine 75mg/m2 i.v d1-d7 (/21d)
Overall Response Rate (ORR) at 6 cycles
The percentage of participants achieving a best overall response of confirmed Complete Response (CR) or Partial Response (PR) after treatment by Anti-PD-1 antibody plus Lenalidomide and Azacitidine.
Complete Response Rate at 6 cycles
The percentage of patients who achieved complete response after treatment by Anti-PD-1 antibody plus Lenalidomide and Azacitidine
3-year progression-free survival (PFS) rate
3-year PFS rate is defined as the percentage of participants who are alive and free from disease progression at 3 years from the first dose of treatment. Participants who are alive and progression-free or lost to follow-up before 3 years will be censored at the date of last adequate tumor assessment.
3-year Overall Survival(OS) Rate
3-year OS rate is defined as the percentage of participants who are alive at 3 years from the first Anti-PD-1 antibody plus Lenalidomide and Azacitidine. Participants who are alive or lost to follow-up before 3 years will be censored at the date of last known follow-up.
Adverse events profile
Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated
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