Single-arm, Multi-center and Phase II Clinical Trial of Camrelizumab Combined With AVD (Epirubicin, Vincristine and Dacarbazine) in the First-line Treatment for Patients With Advanced Classical Hodgkin's Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- Camrelizumab
- Conditions
- Classical Hodgkin Lymphoma
- Sponsor
- Henan Cancer Hospital
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- complete metabolic response rate (CMRR)
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
This is a prospective single-arm, multi-center and 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.
Detailed 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.
Investigators
Yanyan Liu
Director
Henan Cancer Hospital
Eligibility Criteria
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
Arms & Interventions
Camrelizumab Combined With AVD regimen
Camrelizumab 200mg, Intravenous administration on day 1 and day 15 combined with regimen：AVD (Epirubicin, Vincristine and Dacarbazine): repeated every 4 weeks, up to 6 cycles.
Intervention: Camrelizumab
Camrelizumab Combined With AVD regimen
Camrelizumab 200mg, Intravenous administration on day 1 and day 15 combined with regimen：AVD (Epirubicin, Vincristine and Dacarbazine): repeated every 4 weeks, up to 6 cycles.
Intervention: Epirubicin
Camrelizumab Combined With AVD regimen
Camrelizumab 200mg, Intravenous administration on day 1 and day 15 combined with regimen：AVD (Epirubicin, Vincristine and Dacarbazine): repeated every 4 weeks, up to 6 cycles.
Intervention: Vincristine
Camrelizumab Combined With AVD regimen
Camrelizumab 200mg, Intravenous administration on day 1 and day 15 combined with regimen：AVD (Epirubicin, Vincristine and Dacarbazine): repeated every 4 weeks, up to 6 cycles.
Intervention: Dacarbazine
Outcomes
Primary Outcomes
complete metabolic response rate (CMRR)
Time Frame: every 8 weeks from the day of the first cycle of treatment to 4 weeks after the completion of 6 cycles of treatment after the last patient's enrollment (each cycle is 28 days)
the proportion of patients who achieved a complete metabolic response (CMR) as their best overall response (BOR) from the first dose of study treatment through the end-of-treatment (EOT) assessment
Secondary Outcomes
- 2-year progression-free survival(from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment (each cycle is 28 days))
- incidence and relationship with study drugs of grade 3-4 adverse events and abnormal laboratory examinations(from the date of the first cycle of treatment to 1 year after last patient's enrollment (each cycle is 28 days))
- objective response rate(every 8 weeks from the day of the first cycle of treatment to 4 weeks after the completion of 6 cycles of treatment after the last patient's enrollment (each cycle is 28 days))
- duration of complete response(DoCR)(The time from the date of first documented complete response until the date of first documented disease recurrence, progression, or death from any cause, whichever occurs first, assessed up to 10 years.)
- overall survival(from date of the first cycle of treatment to the date of death from any cause, assessed up to 10 years (each cycle is 28 days))