clinical study on anti-pd-1 plus lenalidomide and azacitidine in relapsed/refractory peripheral t-cell lymphoma

Conditions: Relapsed/Refractory Peripheral T-cell Lymphoma

Summary: 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.

peripheral t-cell lymphomas (ptcls) are malignancies of immunologically mature t-cells that arise in peripheral lymphoid tissues. compared with b-cell lymphoma, the treatment methods of ptcl are more limited, the first-line therapy is usually chop-like therapy, but the efficacy is poor, 5-year overall survival rate (os) is only 30%-40%. anti-pd-1 monoclonal antibody, lenalidomide and azacitidine can all have tumor-killing effects, and the three have complementary theoretical basis in the mechanism of action. 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.

Eligibility criteria:
inclusion criteria: 1. 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 \ 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%. 2. age ≥ 18 years. 3. ecog≤2分. 4. 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%. 5. subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up one year period of the study. 6. estimated survival time ≥3 months. 7. voluntary signing of informed consent. exclusion criteria: 1. accepted major surgery within 4 weeks before treatment. 2. 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; 3. patients who have previously received failed allogeneic hematopoietic stem cell transplantation. 4. have stroke or intracranial hemorrhage within 3 months. 5. evidence of complications or medical conditions, including but not limited, that may interfere the conduct of the study or place the patient at serious risk:significant cardiovascular disease(class 3 or 4 cardiac disease as defined by the new york heart association functional classification、myocardial infarction within 6 months of screening、uncontrolled or symptomatic arrhythmias) and/or significant lung disease. 6. hiv infection and/or active hepatitis b or active hepatitis c. 7. uncontrolled systemic infection. 8. pregnant or breasting-feeding women. 9. according to the researchers' judgment, any life-threatening disease, medical condition or organ system dysfunction which can endanger the patient's safety and interfer with the absorption or metabolism of anti-pd-1 monoclonal antibody plus lenalidomide and azacitidine,may put the results of a study at unnecessary risk.

Keywords: anti-pd-1 monoclonal antibody,lenalidomide,azacitidine