SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma
Status:
Recruiting
Trial end date:
2025-03-21
Target enrollment:
Participant gender:
Summary
This is a two-stage, Phase II clinical trial for patients with relapsed or refractory Hodgkin
Lymphoma. The purpose of stage I is to evaluate whether treatment with the study drug
decitabine in combination with SHR-1210 is safe and more effective than treatment with
SHR-1210 alone; and reverse the resistance of anti-PD-1 antibody in patients with HL who had
previously treated with anti-PD-1 monotherapy. If it is deemed that the combination therapy
is more efficacious than SHR-1210 monotherapy (The CR rate of the combination group is at
least 30% higher compared to monotherapy group with a minimal follow-up of 6 months in
predicting 60 subjects naïve to anti-PD-1 antibody who are randomly assigned (2:1) to the
above two groups), the stage II study will be revised to a multicohort,
decitabine-plus-SHR1210 single-arm clinical trial. The primary objective of stage II study is
to evaluate the long-term response duration with decitabine-plus-SHR-1210 in relapsed or
refractory Hodgkin Lymphoma.