Status:
UNKNOWN
SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
12-75 years
Phase:
PHASE2
Brief 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 combin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 21 2025
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT03250962
Start Date
September 11 2017
End Date
March 21 2025
Last Update
April 1 2019
Active Locations (1)
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1
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853