Status:
RECRUITING
Camrelizumab Combined With AVD in the First-line Treatment for Patients With Advanced Classical Hodgkin's Lymphoma
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Classical Hodgkin Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04067037
Start Date
August 26 2019
End Date
December 31 2026
Last Update
April 23 2025
Active Locations (1)
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1
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, China