Clinical trial NCT04067037: Camrelizumab Combined With AVD in the First-line Treatment for Patients With Advanced Classical Hodgkin's Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Classical Hodgkin Lymphoma
Keywords: Classical Hodgkin Lymphoma
PD-1/PD-L1 Signaling Pathway
Camrelizumab
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2019-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: objective response rate
timeFrame: every 8 weeks from the day of the first cycle of treatment to 1 year after last patient's enrollment (each cycle is 28 days)
Secondary outcomes:
measure: 2-year progression-free survival
timeFrame: 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)
measure: overall survival
timeFrame: from date of the first cycle of treatment to the date of death from any cause, assessed up to 5 years (each cycle is 28 days)
measure: incidence and relationship with study drugs of grade 3-4 adverse events and abnormal laboratory examinations
timeFrame: from the date of the first cycle of treatment to 1 year after last patient's enrollment (each cycle is 28 days)
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Yanyan Liu, M.D. Ph.D
role: STUDY_DIRECTOR
References: