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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067037
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Yanyan Liu, Henan Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Classical Hodgkin Lymphoma Drug: Camrelizumab Drug: Epirubicin Drug: Vincristine Drug: Dacarbazine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022


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 Name: 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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) 0-1
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067037


Contacts
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Contact: Yanyan Liu, M.D. Ph.D +8613818176375 yyliu@zzu.edu.cn

Locations
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China, Henan
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university Recruiting
Zhengzhou, Henan, China
Contact: Yanyan Liu, M.D. Ph.D    +8613838176375    yyliu@zzu.edu.cn   
Principal Investigator: Yanyan Liu, M.D. Ph.D         
Sponsors and Collaborators
Henan Cancer Hospital
Investigators
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Study Director: Yanyan Liu, M.D. Ph.D Henan Cancer Hospital
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Responsible Party: Yanyan Liu, Director, Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT04067037    
Other Study ID Numbers: HNSZLYY01
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanyan Liu, Henan Cancer Hospital:
Classical Hodgkin Lymphoma
PD-1/PD-L1 Signaling Pathway
Camrelizumab
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Vincristine
Epirubicin
Dacarbazine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents