Status:
UNKNOWN
Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
12-75 years
Phase:
PHASE2
PHASE3
Brief Summary
This is an open-label, Phase 2/3，multicenter and single-arm clinical trial of Camrelizumab plus decitabine for Anti-PD-1 treatment-naive patients with relapsed or refractory Hodgkin Lymphoma. The prim...
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 two lines of prior regimens without Anti-PD-1 antibody treatment history, 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.
- 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 nvestigational 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 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04510610
Start Date
September 1 2019
End Date
January 1 2025
Last Update
August 12 2020
Active Locations (1)
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1
Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital
Beijing, China, 100853