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

Primary Purpose

Classical Hodgkin Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Camrelizumab
Epirubicin
Vincristine
Dacarbazine
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Classical Hodgkin Lymphoma focused on measuring Classical Hodgkin Lymphoma, PD-1/PD-L1 Signaling Pathway, Camrelizumab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Camrelizumab Combined With AVD regimen

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

2-year progression-free survival
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
overall survival
from date of first day of treatment to the date of death by any cause
incidence and relationship with study drugs of grade 3-4 adverse events and abnormal laboratory examinations
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

Full Information

First Posted
August 18, 2019
Last Updated
May 17, 2023
Sponsor
Henan Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04067037
Brief Title
Camrelizumab Combined With AVD in the First-line Treatment for Patients With Advanced Classical Hodgkin's Lymphoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Classical Hodgkin Lymphoma
Keywords
Classical Hodgkin Lymphoma, PD-1/PD-L1 Signaling Pathway, Camrelizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Camrelizumab Combined With AVD regimen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Other Intervention Name(s)
SHR-1210
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Other Intervention Name(s)
Epirubicin hydrochloride
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Other Intervention Name(s)
Oncovin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dacarbazine
Intervention Description
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 Outcome Measure Information:
Title
objective response rate
Description
the total proportion of patients with complete response (CR) and partial response (PR)
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)
Secondary Outcome Measure Information:
Title
2-year progression-free survival
Description
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
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)
Title
overall survival
Description
from date of first day of treatment to the date of death by any cause
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)
Title
incidence and relationship with study drugs of grade 3-4 adverse events and abnormal laboratory examinations
Description
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
Time Frame
from the date of the first cycle of treatment to 1 year after last patient's enrollment (each cycle is 28 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) 0-1 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanyan Liu, M.D. Ph.D
Phone
+8613818176375
Email
yyliu@zzu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanyan Liu, M.D. Ph.D
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanyan Liu, M.D. Ph.D
Phone
+8613838176375
Email
yyliu@zzu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yanyan Liu, M.D. Ph.D

12. IPD Sharing Statement

Learn more about this trial

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

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