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Clinical Trials in China / NCT04067037
Active, not recruiting Phase 2

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

NCT04067037 · tracked via the Priya Life Science China tracker
Sponsor
Henan Cancer Hospital
Phase
Phase 2
Started
2019-08-26
Last updated
2026-02-02

Condition(s) studied

Classical Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

CamrelizumabEpirubicinVincristineDacarbazine

Camrelizumab: 200mg, Intravenous administration on day 1 and day 15 of each 4-week cycle until disease progression or unacceptable toxicity develops, up to 6 cycles.

Epirubicin: 35mg/m2, Intravenous administration on day 1 and day 15 of each 4-week cycle until disease progression or unacceptable toxicity develops, up to 6 cycles.

Vincristine: 1.4mg/m2, Intravenous administration on day 1 and day 15 of each 4-week cycle until disease progression or unacceptable toxicity develops, up to 6 cycles.

Dacarbazine: 375mg/m2, Intravenous administration on day 1 and day 15 of each 4-week cycle until disease progression or unacceptable toxicity develops, up to 6 cycles.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
An Yang Tumor Hospital Anyang Henan
The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology Luoyang Henan
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university Zhengzhou Henan

More Henan Cancer Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04067037 on ClinicalTrials.gov ↗ ← All trials in China