Camrelizumab(SHR-1210) Combined With GEMOX in Patients With Relapsed or Refractory Hodgkin Lymphoma

An Open-lable, Single Arm, Phase 2 Study of Camrelizumab(SHR-1210) Combined With GEMOX in Patients With Relapsed or Refractory Hodgkin Lymphoma Who Will Receive ASCT

This is an open-label, single arm, Phase 2 study to evaluate efficacy and safety of PD1 inhibitor Camrelizumab(SHR-1210) combined with Gemox in patients with relapsed and refractory hodgkin lymphoma who will receive ASCT.Efficacy will be assessed according to 2014 Lugano criteria.

Study Overview

• Status: Unknown
• Conditions: Hodgkin Lymphoma
• Intervention / Treatment: Drug: Camrelizumab(SHR-1210)

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yuqin Song, MD; Phone Number: (+8610)88196118; Email: SongYQ_VIP@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Jun Zhu, MD; Phone Number: (+8610)88196596; Email: Zj@bjcancer.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histologically confirmed classic Hodgkin's lymphoma ;
2. Relapsed or refractory cHL and meet any of the following criterions:a)did not achieve remission or progression and will receive autologous hematopoietic stem cell transplantation.b)receive no more than 3 lines of systemic chemotherapy.
3. Subjects enrolled have measurable lesion(s) according to Lugano 2014 criteria
4. ECOG performance status of 0 or 1;
5. Life expectancy ≥ 12 weeks.;

6. Adequate laboratory parameters during the screening period as evidenced by the following:

   1. Hemoglobin ≥ 90 g/L;
   2. Absolute neutrophil count ≥ 1.5 × 109/L ;
   3. Platelets ≥ 100 × 109/L;
   4. Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN),
   5. ALT and AST ≤ 2.5×ULN
   6. Serum Creatinine ≤1.25×ULN or Creatinine clearance≥60 mL/min;
   7. Coagulation function index：INR ≤1.5×ULN，APTT≤1.5×ULN
7. Women of childbearing potential（WOCBP）with pregnancy test negative within 7 days before entering the group and consent to employ a highly effective method of birth control/contraception to prevent pregnancy for at least 1 year after receiving the last dose of study treatment; Male subjects with WOCBP partner should receive Surgical sterilization or consent to employ a highly effective method of birth control/contraception to prevent pregnancy for at least 1 year after receiving the last dose of study treatment.
8. Able to understand and sign an informed consent form (ICF).

Exclusion Criteria:

1. Known nodular lymphoma predominant Hodgkin lymphoma

2. History and complication as follows,

   1. Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted
   2. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids > 10 mg/day topical prednisone or equivalent are prohibited within 2 weeks before entering the group
   3. Received anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months before the first dose of trial drugs.
   4. Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody . Or prior exposure to GEMOX but PD.
   5. Participating in other clinical studies or less than 4 weeks before the end of a clinical trial.
   6. Known and highly Suspicion of interstitial pneumonia.
   7. Other active malignancies that required treating. (subjects with skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma or cervical carcinoma who had no disease recurrence within 5 years after the start of treatment were excluded).
   8. Received chemotherapy, radiotherapy,immunotherapy, including topical therapy within 4 weeks. Previous anti-tumor therapy related adverse reactions (except hair loss) did not recover to CTCAE ≤1.
   9. Prior allo-HSCT.
   10. Impact of major surgery or severe trauma had been eliminated for less than 28 days
   11. Active pulmonary tuberculosis.
   12. Severe acute or chronic infection requiring systemic therapy.
   13. Suffering from high blood pressure, and cannot be well controlled by antihypertensive drugs (systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg)
   14. Suffering from heart failure (New York Heart Association standard III or IV). Uncontrolled coronary artery disease and arrhythmia although given appropriate medical treatment. History of myocardial infarction within 6 months.
   15. Three months before randomization, there were significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, stool occult blood test is ++ at baseline and above, or vasculitis

3. Laboratory test

   1. Known HIV positive or known AIDS.
   2. Untreated active hepatitis: Hepatitis B(HBsAg positive and HBV DNA≥500IU/mL), and hepatitis C(HCV RNA positive, abnormal liver function) ,Hepatitis B and hepatitis C infection in common.
4. Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection.
5. Pregnant or lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Camrelizumab(SHR-1210) Combined With GEMOX	Drug: Camrelizumab(SHR-1210); Camrelizumab(SHR-1210): A humanized monoclonal immunoglobulin; Other Names: GEMOX(Gemcitabine, Oxaliplatin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response	Based on Lugano 2014 criteria	From first patient first visit to 3 month after last patient first visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	Rate of subjects achieved complete response plus partial response in all evaluable subjects	From first patient first visit to 3 month after last patient first visit

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (ACTUAL): January 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine; Oxaliplatin
• Other Study ID Numbers: SHR-1210-GEMOX-IIT-HL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No