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

NCT04067037 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: HNSZLYY01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Classical Hodgkin Lymphoma

Keywords

Classical Hodgkin Lymphoma; PD-1/PD-L1 Signaling Pathway; Camrelizumab

Outcome Measures

Primary Outcomes (1)

• complete metabolic response rate (CMRR)

  the proportion of patients who achieved a complete metabolic response (CMR) as their best overall response (BOR) from the first dose of study treatment through the end-of-treatment (EOT) assessment

  every 8 weeks from the day of the first cycle of treatment to 4 weeks after the completion of 6 cycles of treatment after the last patient's enrollment (each cycle is 28 days)

Secondary Outcomes (5)

• objective response rate

  every 8 weeks from the day of the first cycle of treatment to 4 weeks after the completion of 6 cycles of treatment after the last patient's enrollment (each cycle is 28 days)

• duration of complete response(DoCR)

  The time from the date of first documented complete response until the date of first documented disease recurrence, progression, or death from any cause, whichever occurs first, assessed up to 10 years.

• 2-year progression-free survival

  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)

• overall survival

  from date of the first cycle of treatment to the date of death from any cause, assessed up to 10 years (each cycle is 28 days)

• incidence and relationship with study drugs of grade 3-4 adverse events and abnormal laboratory examinations

  from the date of the first cycle of treatment to 1 year after last patient's enrollment (each cycle is 28 days)

Study Arms (1)

Camrelizumab Combined With AVD regimen

EXPERIMENTAL

Camrelizumab 200mg, Intravenous administration on day 1 and day 15 combined with regimen：AVD (Epirubicin, Vincristine and Dacarbazine): repeated every 4 weeks, up to 6 cycles.

Drug: Camrelizumab; Drug: Epirubicin; Drug: Vincristine; Drug: Dacarbazine

Interventions

Camrelizumab DRUG

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.

Also known as: SHR-1210

Camrelizumab Combined With AVD regimen

Epirubicin DRUG

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.

Also known as: Epirubicin hydrochloride

Camrelizumab Combined With AVD regimen

Vincristine DRUG

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.

Also known as: Oncovin

Camrelizumab Combined With AVD regimen

Dacarbazine DRUG

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.

Camrelizumab Combined With AVD regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (3)

An Yang Tumor Hospital

Anyang, Henan, 455000, China

Location

The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology

Luoyang, Henan, 471003, China

Location

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

Location

MeSH Terms

Interventions

camrelizumab; Epirubicin; Vincristine; Dacarbazine

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Yanyan Liu, M.D. Ph.D

  Henan Cancer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 18, 2019
• First Posted: August 26, 2019
• Study Start: August 26, 2019
• Primary Completion: January 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

CN (3)