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

May 17, 2023 updated by: Yanyan Liu, Henan Cancer Hospital

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yanyan Liu, M.D. Ph.D
  • Phone Number: +8613818176375
  • Email: yyliu@zzu.edu.cn

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
        • Contact:
        • Principal Investigator:
          • Yanyan Liu, M.D. Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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) 0-1
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Camrelizumab Combined With AVD regimen
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
30mg, 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
Drug: 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.
Other Names:
  • Epirubicin hydrochloride
Drug: 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.
Other Names:
  • Oncovin
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate
Time Frame: every 8 weeks from the day of the first cycle of treatment to 1 year after last patient's enrollment (each cycle is 28 days)
the total proportion of patients with complete response (CR) and partial response (PR)
every 8 weeks from the day of the first cycle of treatment to 1 year after last patient's enrollment (each cycle is 28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: from date of the first cycle of treatment to the date of death from any cause, assessed up to 5 years (each cycle is 28 days)
from date of first day of treatment to the date of death by any cause
from date of the first cycle of treatment to the date of death from any cause, assessed up to 5 years (each cycle is 28 days)
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
from the date of the first cycle of treatment to 1 year after last patient's enrollment (each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Cancer Hospital

Investigators

  • Study Director: Yanyan Liu, M.D. Ph.D, Henan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2019

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

August 18, 2019

First Submitted That Met QC Criteria

August 21, 2019

First Posted (Actual)

August 26, 2019

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HNSZLYY01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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