Anti-PD-1 Antibody Resistant, Hodgkin Lymphoma
Conditions
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 patients with Hodgkin Lymphoma who were confirmed resistant to Anti-PD-1 antibody therapy.
Interventions
DRUGChidamide; Decitabine; Camrelizumab
Chidamide is a novel and orally active benzamide class of HDAC inhibitor that selectively inhibits activity of HDAC1, 2, 3 and 10, which can Induce tumor-cell apoptosis, suppress cell proliferation and enhance immune surveillance. Decitabine is an investigational (experimental) drug that works by depleting DNA methyltransferase 1(DNMT1), which can increase tumor antigens and HLA expression, enhances antigen processing, promotes T cell infiltration, and boosts effector T cell function. Camrelizumab is a humanized anti-PD-1 monoclonal antibody.
DRUGDecitabine+Camrelizumab
Decitabine+Camrelizumab
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
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 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. 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 illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR assess by investigators per the 2014 Lugano classification | 3 years | rate of subjects achieved objective response in all evaluable subjects |
| Number of Subjects with treatment-related adverse events (AEs) | 3 years | Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. |
Countries
China
Contacts
Primary ContactWeidong Han, M.D.
Outcome results
None listed