SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma
Hodgkin Lymphoma
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Relapsed/Refractory; Hodgkin Lymphoma;Decitabine; SHR-1210
Eligibility Criteria
Inclusion Criteria:
1 Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
2 12 to 75 years of age. 3 ECOG performance of less than 2. 4 Life expectancy of at least 3 months. 5 Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria.
6 Subjects must have received at least four prior chemotherapy regimen, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.Subjects with Anti-PD-1 antibody are eligible which must be resistance.
7 Subjects must have adequate marrow, live, renal and heart functions.
Exclusion Criteria:
1 Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
2 Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
3 Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
4 Prior organ allograft. 5 Women who are pregnant or breastfeeding. 6 Women with a positive pregnancy test on enrollment or prior to investigational product administration.
7 Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Sites / Locations
- Biotherapeutic Department of Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
SHR-1210-plus-Decitabine
SHR-1210
Decitabine 10 mg/day, days 1-5; SHR-1210 200 mg, day 8, every 3 weeks.
SHR-1210 200 mg, day 1, every 3 weeks.