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Sintilimab in Combination With R-CHOP in Patients With Treatment-naive EBV-positive DLBCL, NOS

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. Identifier: NCT04181489
Recruitment Status : Recruiting
First Posted : November 29, 2019
Last Update Posted : November 29, 2019
Information provided by (Responsible Party):
WEI XU, The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
The prognosis of EBV+ DLBCL is dismal. Previous study showed that high level of PD-L1 expression in EBV+ DLBCL. The investigators therefore design this phase II study to investigate the safety and efficacy of sintilimab (an anti-PD-1 antibody) in combination with R-CHOP in patients with treatment-naive EBV+ DLBCL.

Condition or disease Intervention/treatment Phase
EBV-Positive DLBCL, Nos Drug: Sintilimab Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisolone Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Prospective, Multi-center Study of Sintilimab in Combination With R-CHOP in Patients With Treatment-naive EBV-positive DLBCL, NOS
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sintilimab + R-CHOP Drug: Sintilimab
Sintilimab 200mg d0

Drug: Rituximab
Rituximab 375 mg/m2 d0

Drug: Cyclophosphamide
Cyclophosphamide 750 mg/m2 d1

Drug: Doxorubicin
Doxorubicin 50 mg/m2 d1

Drug: Vincristine
Vincristine 1.4mg/m2 (maximum 2mg) d1

Drug: Prednisolone
Prednisolone 60mg/m2 d1-5

Primary Outcome Measures :
  1. Progressive free survival [ Time Frame: 2 years ]
    from date of inclusion to date of progression, relapse, or death from any cause

Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: 6 months ]
    overall response rate after treated by Sintilimab and R-CHOP

  2. Overall survival [ Time Frame: 2 years ]
    from the date of inclusion to date of death, irrespective of cause

  3. Incidence of treatment related adverse events as assessed by NCI-CTCAE 5.0 [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

1. Histologically confirmed EBV-positive diffuse large B cell lymphoma, NOS, according to WHO 2016 criteria.

2. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.

3. Undergo whole-body PET/CT scan 28 days before enrolment and have a measurable or evaluable disease (nodal lesion: diameter ≥ 1.5cm; extranodal lesion≥1.0cm)according to Lugano 2014 criteria; 4. ECOG PS 0- 2; 5. Adequate organ function, defined as:

  1. Blood routine test: neutrophil count ≥ 1.0×10⁹/L, platelet count ≥ 50×10⁹/L, hemoglobulin ≥8.0g/dL, without G-CSF usage or blood infusion within 7 days before examination.
  2. Hepatic function: total bilirubin less than 1.5-fold of upper normal level; ALT and AST less than 2-fold of upper normal level.
  3. Renal function: Serum creatine less than 1.5-fold of upper normal level or Ccr ≥ 50 mL/min.
  4. Cardiac function: New York Heart Association class II or below (EF≥ 50% according to TDE)
  5. Coagulative function: INR less than 1.5-fold of upper normal level, APTT less than 10s above upper normal level and PT less than 3s above upper normal level;
  6. Thyroid function: normal baseline TSH level, or abnormal baseline TSH but normal T3/T4 level without symptoms; 6. Expected survival ≥ 3 months; 7. Age 18~70 years; 8. Female subjects in childbearing age, their serum or urine pregnancy test must be negative. All patients must agree to take effective contraceptive measures during treatment and 90 days after treatment.

Exclusion Criteria:

  1. CNS or meningeal involvement;
  2. Patients with secondary tumour, excluding cured (5 years without relapse) in situ Non-melanoma skin cancer. superficial bladder cancer, in situ cervical cancer, Gastrointestinal intramucous carcinoma and breast cancer;
  3. Known sensitivity or allergy to investigational product;
  4. Previous exposure to anti PD-1 antibody, anti PD-L1 antibody, anti PD-L2 antibody, anti CTLA-4 antibody, CAR-T therapy or any T cell co-stimulating antibody or checkpoint inhibitor;
  5. Previous allogeneic organ transplantation or allogeneic stem cell transplantation;
  6. Intention to use any other anti-tumour therapy during treatment;
  7. Use of systemic anti-tumour treatment within 3 months before first dose of study regimen;
  8. Active and severe infectious diseases requiring systemic treatment;
  9. Active (known or suspected) autoimmune disease or history of autoimmune disease within 2 years before treatment (excluding patients with leukoderma, psoriasis, lipsotrichia or Grave's disease who do not require systemic treatment within 2 years, patients with hypothyrea only requiring thyroxine as treatment, and patients with type I diabetes but only requiring insulin treatment)
  10. Usage of immune inhibitory drugs 4 weeks before the first dose of study regimen, excluding local usage of glucocorticoid and systemic usage of less than 10mg/d Prednisone or equivalent glucocorticoid.
  11. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected persons;
  12. Previous history of Idiopathic pulmonary fibrosis or Idiopathic pneumonia;
  13. Active tuberculosis;
  14. Presence of ≥ Grade 3 immune therapy related toxicity;
  15. History of mental disorder including epilepsia and dementia;
  16. Any anti-infectious vital vaccine usage 4 weeks before the first dose or during treatment;
  17. Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment;
  18. Women who are pregnant or lactating.
  19. Usage of other experimental drugs within 1 month before treatment;
  20. In any conditions which investigator considered ineligible for this study

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 identifier (NCT number): NCT04181489

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Contact: yi xia, M.D., Ph.D. 025-68306034
Contact: Wei Xu, M.D., Ph.D. 025-68306034

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China, Jiangsu
ChangZhou First People's Hospital Recruiting
ChangZhou, Jiangsu, China, 213003
Contact: XiangShan Cao, M.D., Ph.D.         
Principal Investigator: XiangShan Cao, M.D., Ph.D.         
ChangZhou No.2 People's Hospital Recruiting
ChangZhou, Jiangsu, China, 213011
Contact: Min Zhou, Dr.         
Principal Investigator: Min Zhou, M.D.         
HuaiAn First People's Hospital Recruiting
HuaiAn, Jiangsu, China, 223300
Contact: Liang Yu, Dr.         
Principal Investigator: Liang Yu, M.D., Ph.D.         
Drum tower hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Jingyan Xu, M.D., Ph.D.         
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital) Recruiting
NanJing, Jiangsu, China, 21002
Contact: Yi Xia, M.D., Ph.D.    +86 25 68136034   
Principal Investigator: Wei Xu, M.D., Ph.D.         
The First Affiliated Hospital Of Nantong University Recruiting
Nantong, Jiangsu, China, 226000
Contact: Wenyu Shi, M.D., Ph.D.         
The Second Affiliated Hospital Of Suzhou University Recruiting
Suzhou, Jiangsu, China, 215000
Contact: Bingzong Li, M.D., Ph.D.         
WuXi People's Hospital Recruiting
WuXi, Jiangsu, China, 214023
Contact: Yun Zhuang, M.D.         
Principal Investigator: YunFeng Shen, M.D., Ph.D.         
Xuzhou Central Hospital Recruiting
Xuzhou, Jiangsu, China, 221000
Contact: Xiaolin Li, M.D., Ph.D.         
Yancheng First People's Hospital Recruiting
Yancheng, Jiangsu, China, 224000
Contact: Hao Xu, M.D., Ph.D.         
ZhenJiang First People's Hospital Recruiting
ZhenJiang, Jiangsu, China, 212002
Contact: Yan Zhu, Dr.         
Principal Investigator: Yan Zhu, M.D., Ph.D.         
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
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Principal Investigator: Wei Xu, M.D., Ph.D. The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

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Responsible Party: WEI XU, Professor, The First Affiliated Hospital with Nanjing Medical University Identifier: NCT04181489    
Other Study ID Numbers: 2019-SR-271
First Posted: November 29, 2019    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 WEI XU, The First Affiliated Hospital with Nanjing Medical University:
EBV-Positive DLBCL, nos
Additional relevant MeSH terms:
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Lymphoma, Large B-Cell, Diffuse
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic