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NCT Number: NCT04067037

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Classical Hodgkin Lymphoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

An Yang Tumor Hospital, Anyang, Henan, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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) 0-2
  • 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 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

Treatment and study plan

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.

Other names: SHR-1210

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.

Other names: Epirubicin hydrochloride

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.

Other names: Oncovin

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.

Primary outcomes

  1. complete metabolic response rate (CMRR)

    Time frame: 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)

    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

Secondary outcomes

  1. objective response rate

    Time frame: 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)

    the total proportion of patients with complete response (CR) and partial response (PR)

  2. duration of complete response(DoCR)

    Time frame: 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.

    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.

  3. 2-year progression-free survival

    Time frame: 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)

    the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurrs first

  4. overall survival

    Time frame: 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)

    from date of first day of treatment to the date of death by any cause

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

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

    the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03) and abnormal laboratory examinations

Sponsors and collaborators

Lead sponsor

Henan Cancer Hospital

Other Gov

Registry information

Official study title

Single-arm, Multi-center and 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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2019
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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