Hodgkin Lymphoma
Conditions
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 primary objective of this study is to evaluate the long-term response duration with Camrelizumab plus decitabine in relapsed or refractory Hodgkin Lymphoma.
Interventions
DRUGCamrelizumab and Decitabine
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.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 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 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 nvestigational product administration. * 7 Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| duration of response | 5 years | Time measured from the day of first documented PR or CR to the date of first documented progression, or death from any cause. |
| Progression free survival | 5 years | Time measured from the day of treatment to the date of first documented progression, or death from any cause |
Countries
China
Contacts
Primary ContactWeidong Han, M.D.
Outcome results
None listed