Camrelizumab Combined With AVD in the First-line Treatment for Patients With Advanced Classical Hodgkin's Lymphoma

Henan Cancer Hospital

Status and phase: Active, not recruiting; Phase 2

Conditions: Classical Hodgkin Lymphoma

Treatments: Drug: Dacarbazine; Drug: Vincristine; Drug: Epirubicin; Drug: Camrelizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04067037

HNSZLYY01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18 to 75 years old (including 18 and 75)
2. Diagnosed as advanced classical hodgkin's lymphoma based on histopathology
3. Subjects must be untreated (Ann Arbor Stage III/IV or Ann Arbor II with B symptoms along with mediastinal big tumor or extranodal changes)
4. No receiving chemotherapy before enrollment
5. Having at least one measurable lesions
6. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
7. Life expectancy no less than 3 months
8. enough main organ function
9. 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
10. Agreeing to sign the written informed consents

Exclusion criteria

1. Diagnosed as nodular lymphocyte predominant lymphoma or grey-zone lymphoma
2. Diagnosed as central nervous system lymphoma
3. usage of immunosuppressants before enrollment and the dose of immunosuppressant used >10mg / day oral prednisone for more than 2 weeks
4. Previously treated with anti-PD-1/PD-L1/PD-L2/CTLA-4
5. Active autoimmune disease
6. Vaccination with anti-tumor vaccine or other immune treatments less than 3 months
7. Serious surgery and trauma less than two weeks
8. Other malignant tumor history or active malignant tumor need be treated
9. Systemic therapy for serious acute/chronic infection
10. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
11. Active tuberculosis
12. Vaccination with live attenuated vaccine less than 4 weeks
13. HIV-positive, AIDS patients and untreated active hepatitis
14. Researchers determine unsuited to participate in this trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Camrelizumab Combined With AVD regimen

Experimental group

Description:

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.

Treatment:

Drug: Camrelizumab

Drug: Epirubicin

Drug: Vincristine

Drug: Dacarbazine