SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma

  • STATUS
    Recruiting
  • End date
    Mar 21, 2025
  • participants needed
    280
  • sponsor
    Chinese PLA General Hospital
Updated on 22 January 2021
lymphoma
cell transplantation
chemotherapy regimen
refractory hodgkin lymphoma

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 nave 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.

Details
Condition Hodgkin's Disease, Lymphoma, hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma
Treatment Decitabine, SHR-1210
Clinical Study IdentifierNCT03250962
SponsorChinese PLA General Hospital
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL)
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
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
Subjects must have adequate marrow, live, renal and heart functions

Exclusion Criteria

Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications
Serious uncontrolled medical disorders or active infections, pulmonary
infection especially
Active alimentary tract hemorrhage or history of alimentary tract hemorrhage
in 1 month
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
Subjects who are compulsorily detained for treatment of either a psychiatric
or physical (eg, infectious disease) illness
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