pd-1 inhibitor or pd-1 inhibitor plus gvd for relapsed/refractory chl

Conditions: Classical Hodgkin Lymphoma; Refractory or Relapsed Classical Hodgkin Lymphoma

Summary: this phase 2 trial studies the efficacy and safety of pd-1 inhibitor monotherapy or pd-1 inhibitor with gvd (gemcitabine, vinorelbine and doxorubicin liposome) regimen for relapsed or refractory classical hodgkin lymphoma (chl) patients who failed the first-line induction therapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed classical hodgkin lymphoma; * refractory to or relapsed after first-line induction therapy; prior radiotherapy is allowed; * at least one evaluable lesion according to 2014 lugano criteria; * life expectancy \> 3 months; * eastern cooperative oncology group (ecog) of 0-1; * able to participate in all required study procedures; * proper functioning of the major organs: 1) the absolute value of neutrophils (\>1.5×10\^9/l); 2) platelet count (\> 75×10\^9/l); 3) hemoglobin (\> 80 g/l); 4) serum creatinine \<1.5 times upper limit normal (uln) ; 5) serum total bilirubin \< 1.5 times uln; 6) aspartate aminotransferase (ast), alanine aminotransferase (alt) \< 2.5 times uln; 7) coagulation function: international normalized ratio (inr), prothrombin time (pt), activated partial thromboplastin time (aptt) \< 1.5 times uln (unless the subject is receiving anticoagulant therapy and pt and aptt are within the expected range at screening time). ; 8) thyrotropin (tsh) or free thyroxine (ft4) or free triiodothyronine (ft3) were all within the normal range (±10%); * there was no evidence that subjects had difficulty breathing at rest, and the measured value of pulse oximetry at rest was more than 92%; * volunteers who signed informed consent. exclusion criteria: * involvement of central nervous system (cns); * previously received treatment of immune checkpoint inhibitors (eg. pd-1, pd-l1, ctla-4); * previously received treatment of hematopoietic cell transplantation; * patients with hemophagocytic syndrome; * patients with active autoimmune diseases requiring systematic treatment in the past two years (hormone replacement therapy is not considered systematic treatment, such as type i diabetes mellitus, hypothyroidism requiring only thyroxine replacement therapy, adrenocortical dysfunction or pituitary dysfunction requiring only physiological doses of glucocorticoid replacement therapy); patients with autoimmune diseases who do not require systematic treatment within two years can be enrolled; * requiring treatment with corticosteroids or other immunosuppressive drugs within 14 days of study drug administration \[allowing subjects to use local, ocular, intra-articular, intranasal and inhaled glucocorticoid therapy (with very low systemic absorption); and allowing short-term (\< 7 days) glucocorticoid prophylaxis (e.g., contrast agent overdose sensitivity) or for the treatment of non-autoimmune diseases (e.g. delayed hypersensitivity caused by contact allergens). * uncontrolled active infection, with the exception of tumor-related b symptom fever; * history of human immunodeficiency virus (hiv) infection and/or patients with acquired immunodeficiency syndrome are known; * patients with active hepatitis b or active hepatitis c. patients who are positive for hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv) antibodies at screening stage must pass further detection of hepatitis b virus (hbv) dna (no more than 10\^4 copies/ml) and hcv rna (no more than the lower limit of the detection method) in the row. hepatitis b carriers, stable hepatitis b (dna titer should not be higher than 10\^4 copies/ml) after drug treatment, and cured hepatitis c patients can be enrolled in the group; * diagnosed with or receiving treatment for malignancy other than lymphoma; * pregnant or breastfeeding women; * other researchers consider it unsuitable for patients to participate in this study.