A Randomized, Open, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Penpulimab Monotherapy vs. Standard Chemotherapy Selected by Investigator in the Relapsed and Refractory Classical Hodgkin's Lymphoma (R/R cHL)
This is an open-label, multicenter, randomized, phase 3 trial to evaluate the efficacy of Penpulimab vs. standard chemotherapy selected by investigator in patients with relapsed or refractory classic Hodgkin's lymphoma.
• Signed written informed consent form (ICF).
• Age of ≥ 18 years at the time of enrollment, male or female.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of ≥ 3 months.
• Histologically confirmed classic Hodgkin's lymphoma (cHL).
• Relapsed (disease progression during or after most recent therapy) or refractory (failure to achieve CR or PR after most recent therapy) cHL and meet any of the following criterions:
‣ Subjects who have received autologous hematopoietic stem cell transplantation (ASCT) after salvage chemotherapy, followed by relapse or progression.
⁃ For subjects who have not received ASCT, it is required at least 2 lines of prior systemic chemotherapy. Refractory subjects are defined as failure to achieve PR after at least 2 cycles of chemotherapy, or failure to achieve CR after at least 4 cycles of chemotherapy. If the best response to treatment is PD or the reason for ending the treatment is PD, the subject is considered as refractory without requirement on the number of cycles of treatment received.
• Have at least one measurable lesion according to Lugano classification 2014.
• Have adequate hematologic and organ function as defined below:
‣ Hematology (supportive treatment with ang blood components or cell growth factors is not allowed within 7 days prior to enrollment laboratory test): Absolute neutrophil count (ANC) ≥ 1.0x109/L, platelet count ≥ 75 x109/L, hemoglobin ≥ 80g/L.
⁃ Kidney: Serum creatinine ≤ 1.5 X ULN and estimated GFR (by Cockroft-Gault equation) ≥ 50ml/min.
⁃ Liver: Total bilirubin ≤ 1.5 X ULN, AST/ALT ≤ 2.5 X ULN.
⁃ Coagulation: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
• Women of childbearing potential (WOCBP) must be tested for serum or urine pregnancy negative within 3 days prior to the first dose of study treatment. WOCBP will be instructed to adhere to contraception while on treatment and for at least 150 days after the last dose of study treatment. Male subjects who are sexually active with WOCBP will be instructed to adhere to contraception while on treatment and for at least 150 days after receiving the last dose of study treatment.