Camrelizumab with AVD for advanced classical Hodgkin's lymphoma
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
This study is testing a new combination of a drug called Camrelizumab with standard chemotherapy to see if it helps people with advanced classical Hodgkin's lymphoma who haven't had treatment before.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Henan Cancer Hospital Government |
| Drugs / interventions | chemotherapy, prednisone, Camrelizumab, Nivolumab, Pembrolizumab |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT04067037 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial aims to evaluate the efficacy and safety of Camrelizumab, an anti-PD-1 monoclonal antibody, combined with AVD (Epirubicin, Vincristine, and Dacarbazine) as a first-line treatment for patients with advanced classical Hodgkin's lymphoma. The study focuses on patients who have not received prior chemotherapy and have measurable lesions. By targeting the PD-1/PD-L1 signaling pathway, the trial seeks to improve outcomes for patients who are at risk of relapse and drug resistance. The trial will monitor both the effectiveness of the treatment and any associated safety concerns.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with untreated advanced classical Hodgkin's lymphoma and measurable lesions.
Not a fit: Patients with nodular lymphocyte predominant lymphoma, central nervous system lymphoma, or those who have received prior chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective first-line therapy for patients with advanced classical Hodgkin's lymphoma, potentially reducing relapse rates.
How similar studies have performed: Other studies have shown promising results using PD-1 inhibitors in relapsed and refractory Hodgkin's lymphoma, suggesting potential for success with this novel combination approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zhengzhou, Henan
- Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Yanyan Liu, M.D. Ph.D
- Email: yyliu@zzu.edu.cn
- Phone: +8613818176375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.