Sintilimab in Combination With R-CHOP in Patients With Treatment-naive EBV-positive DLBCL, NOS
NCT ID: NCT04181489
Last Updated: 2019-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
55 participants
INTERVENTIONAL
2019-01-01
2023-12-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sintilimab + R-CHOP
Sintilimab
Sintilimab 200mg d0
Rituximab
Rituximab 375 mg/m2 d0
Cyclophosphamide
Cyclophosphamide 750 mg/m2 d1
Doxorubicin
Doxorubicin 50 mg/m2 d1
Vincristine
Vincristine 1.4mg/m2 (maximum 2mg) d1
Prednisolone
Prednisolone 60mg/m2 d1-5
Interventions
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Sintilimab
Sintilimab 200mg d0
Rituximab
Rituximab 375 mg/m2 d0
Cyclophosphamide
Cyclophosphamide 750 mg/m2 d1
Doxorubicin
Doxorubicin 50 mg/m2 d1
Vincristine
Vincristine 1.4mg/m2 (maximum 2mg) d1
Prednisolone
Prednisolone 60mg/m2 d1-5
Eligibility Criteria
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Inclusion 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
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
18 Years
70 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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WEI XU
Professor
Principal Investigators
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Wei Xu, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Locations
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ChangZhou First People's Hospital
Changzhou, Jiangsu, China
ChangZhou No.2 People's Hospital
Changzhou, Jiangsu, China
HuaiAn First People's Hospital
HuaiAn, Jiangsu, China
Drum tower hospital
Nanjing, Jiangsu, China
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Nanjing, Jiangsu, China
The First Affiliated Hospital Of Nantong University
Nantong, Jiangsu, China
The Second Affiliated Hospital Of Suzhou University
Suzhou, Jiangsu, China
WuXi People's Hospital
Wuxi, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Yancheng First People's Hospital
Yancheng, Jiangsu, China
ZhenJiang First People's Hospital
Zhenjiang, Jiangsu, China
Countries
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Central Contacts
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Wei Xu, M.D., Ph.D.
Role: CONTACT
Phone: 025-68306034
Facility Contacts
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XiangShan Cao, M.D., Ph.D.
Role: primary
Min Zhou, Dr.
Role: primary
Liang Yu, Dr.
Role: primary
Jingyan Xu, M.D., Ph.D.
Role: primary
Yi Xia, M.D., Ph.D.
Role: primary
Wenyu Shi, M.D., Ph.D.
Role: primary
Bingzong Li, M.D., Ph.D.
Role: primary
Yun Zhuang, M.D.
Role: primary
Xiaolin Li, M.D., Ph.D.
Role: primary
Hao Xu, M.D., Ph.D.
Role: primary
Yan Zhu, Dr.
Role: primary
References
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Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, Advani R, Ghielmini M, Salles GA, Zelenetz AD, Jaffe ES. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016 May 19;127(20):2375-90. doi: 10.1182/blood-2016-01-643569. Epub 2016 Mar 15.
Coiffier B, Thieblemont C, Van Den Neste E, Lepeu G, Plantier I, Castaigne S, Lefort S, Marit G, Macro M, Sebban C, Belhadj K, Bordessoule D, Ferme C, Tilly H. Long-term outcome of patients in the LNH-98.5 trial, the first randomized study comparing rituximab-CHOP to standard CHOP chemotherapy in DLBCL patients: a study by the Groupe d'Etudes des Lymphomes de l'Adulte. Blood. 2010 Sep 23;116(12):2040-5. doi: 10.1182/blood-2010-03-276246. Epub 2010 Jun 14.
Ahn JS, Yang DH, Duk Choi Y, Jung SH, Yhim HY, Kwak JY, Sung Park H, Shin MG, Kim YK, Kim HJ, Lee JJ. Clinical outcome of elderly patients with Epstein-Barr virus positive diffuse large B-cell lymphoma treated with a combination of rituximab and CHOP chemotherapy. Am J Hematol. 2013 Sep;88(9):774-9. doi: 10.1002/ajh.23507. Epub 2013 Jul 23.
Sato A, Nakamura N, Kojima M, Ohmachi K, Carreras J, Kikuti YY, Numata H, Ohgiya D, Tazume K, Amaki J, Moriuchi M, Miyamoto M, Aoyama Y, Kawai H, Ichiki A, Hara R, Kawada H, Ogawa Y, Ando K. Clinical outcome of Epstein-Barr virus-positive diffuse large B-cell lymphoma of the elderly in the rituximab era. Cancer Sci. 2014 Sep;105(9):1170-5. doi: 10.1111/cas.12467. Epub 2014 Sep 8.
Hong JY, Yoon DH, Suh C, Huh J, Do IG, Sohn I, Jo J, Jung SH, Hong ME, Yoon H, Ko YH, Kim SJ, Kim WS. EBV-positive diffuse large B-cell lymphoma in young adults: is this a distinct disease entity? Ann Oncol. 2015 Mar;26(3):548-55. doi: 10.1093/annonc/mdu556. Epub 2014 Dec 4.
Lu TX, Liang JH, Miao Y, Fan L, Wang L, Qu XY, Cao L, Gong QX, Wang Z, Zhang ZH, Xu W, Li JY. Epstein-Barr virus positive diffuse large B-cell lymphoma predict poor outcome, regardless of the age. Sci Rep. 2015 Jul 23;5:12168. doi: 10.1038/srep12168.
Xu-Monette ZY, Zhou J, Young KH. PD-1 expression and clinical PD-1 blockade in B-cell lymphomas. Blood. 2018 Jan 4;131(1):68-83. doi: 10.1182/blood-2017-07-740993. Epub 2017 Nov 8.
Other Identifiers
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2019-SR-271
Identifier Type: -
Identifier Source: org_study_id