Status:
UNKNOWN
The Clinical Trial of Chidamide+Decitabine+Camrelizumab Versus Decitabine+Camrelizumab in Anti-PD-1 Antibody Resistant Patients With Classical Hodgkin Lymphoma.
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Hodgkin Lymphoma
Anti-PD-1 Antibody Resistant
Eligibility:
All Genders
12-75 years
Phase:
PHASE2
Brief Summary
This open-label, randomized, two-arm, phase 2 study has the primary objective of comparing the ORR obtained with Chidamide+Decitabine+Camrelizumab against that obtained with Decitabine+Camrelizumab in...
Eligibility Criteria
Inclusion
- Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
- 12 to 75 years of age.
- ECOG performance of less than 2.
- Life expectancy of at least 3 months.
- Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria.
- Subjects must have received Anti-PD-1 antibody therapy and were confirmed Anti-PD-1 antibody resistant. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
- Subjects must have adequate marrow, live, renal and heart functions.
Exclusion
- 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.
- Women who are pregnant or breastfeeding.
- 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 illness.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04514081
Start Date
August 1 2020
End Date
August 1 2025
Last Update
August 18 2020
Active Locations (1)
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1
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853