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

  • STATUS
    Recruiting
  • End date
    Jun 27, 2024
  • participants needed
    60
  • sponsor
    Henan Cancer Hospital
Updated on 27 January 2021
lymphoma
vincristine
dacarbazine
epirubicin
camrelizumab

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.

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.

Details
Condition Classical Hodgkin Lymphoma
Treatment Epirubicin, vincristine, dacarbazine, Camrelizumab
Clinical Study IdentifierNCT04067037
SponsorHenan Cancer Hospital
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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) 0-1
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
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