Overview
This is a prospective phase II clinical trial to observe the efficacy and safety of Camrelizumab combined with AVD in the first-line treatment for patients with advanced classical Hodgkin's lymphoma.
Description
Hodgkin's lymphoma (HL) is a kind of malignant tumor of the lymph system, approximately 95% of which are classical hodgkin's lymphoma (cHL). Currently, ABVD and BEACOPP are commonly used in the first-line treatment for cHL. There are about one third of patients, whose pre-treatment assessment are mainly advanced cHL, suffering relapse and drug resistance. PD-1/PD-L1 signaling pathway plays an important role in the development and progression of cHL. Nivolumab and Pembrolizumab have been used in the therapy in relapsed and refractory patients with cHL. Camrelizumab, a humanized anti-PD-1 IgG4 monoclonal antibody, is independently developed in China. The goal of our trial is to assess the efficacy and safety of Camrelizumab combined with AVD (Epirubicin, Vincristine and Dacarbazine) in the first-line treatment for patients with advanced classical Hodgkin's lymphoma.
Eligibility
Inclusion Criteria:
- Age between 18 to 75 years old (including 18 and 75)
- Diagnosed as advanced classical hodgkin's lymphoma based on histopathology
- Subjects must be untreated (Ann Arbor Stage III/IV or Ann Arbor II with B symptoms along with mediastinal big tumor or extranodal changes)
- No receiving chemotherapy before enrollment
- Having at least one measurable lesions
- World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
- Life expectancy no less than 3 months
- enough main organ function
- Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
- Agreeing to sign the written informed consents
Exclusion Criteria:
- Diagnosed as nodular lymphocyte predominant lymphoma or grey-zone lymphoma
- Diagnosed as central nervous system lymphoma
- usage of immunosuppressants before enrollment and the dose of immunosuppressant used >10mg / day oral prednisone for more than 2 weeks
- Previously treated with anti-PD-1/PD-L1/PD-L2/CTLA-4
- Active autoimmune disease
- Vaccination with anti-tumor vaccine or other immune treatments less than 3 months
- Serious surgery and trauma less than two weeks
- Other malignant tumor history or active malignant tumor need be treated
- Systemic therapy for serious acute/chronic infection
- Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
- Active tuberculosis
- Vaccination with live attenuated vaccine less than 4 weeks
- HIV-positive, AIDS patients and untreated active hepatitis
- Researchers determine unsuited to participate in this trial