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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab + R-CHOP | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | Sintilimab 200mg d0 |
| |
| Rituximab |
| Measure | Description | Time Frame |
|---|---|---|
| Progressive free survival | from date of inclusion to date of progression, relapse, or death from any cause | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | overall response rate after treated by Sintilimab and R-CHOP | 6 months |
| Overall survival | from the date of inclusion to date of death, irrespective of cause |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yi xia, M.D., Ph.D. | Contact | 025-68306034 | cynthia0311@163.com | |
| Wei Xu, M.D., Ph.D. | Contact | 025-68306034 |
| Name | Affiliation | Role |
|---|---|---|
| Wei Xu, M.D., Ph.D. | The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ChangZhou First People's Hospital | Recruiting | Changzhou | Jiangsu | 213003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26980727 | Background | 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. | |
| 20548096 | Background |
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| Drug |
Rituximab 375 mg/m2 d0 |
|
| Cyclophosphamide | Drug | Cyclophosphamide 750 mg/m2 d1 |
|
| Doxorubicin | Drug | Doxorubicin 50 mg/m2 d1 |
|
| Vincristine | Drug | Vincristine 1.4mg/m2 (maximum 2mg) d1 |
|
| Prednisolone | Drug | Prednisolone 60mg/m2 d1-5 |
|
| 2 years |
| Incidence of treatment related adverse events as assessed by NCI-CTCAE 5.0 | 2 years |
| ChangZhou No.2 People's Hospital | Recruiting | Changzhou | Jiangsu | 213011 | China |
|
| HuaiAn First People's Hospital | Recruiting | HuaiAn | Jiangsu | 223300 | China |
|
| Drum tower hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
|
| The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital) | Recruiting | Nanjing | Jiangsu | 21002 | China |
|
| The First Affiliated Hospital Of Nantong University | Recruiting | Nantong | Jiangsu | 226000 | China |
|
| The Second Affiliated Hospital Of Suzhou University | Recruiting | Suzhou | Jiangsu | 215000 | China |
|
| WuXi People's Hospital | Recruiting | Wuxi | Jiangsu | 214023 | China |
|
| Xuzhou Central Hospital | Recruiting | Xuzhou | Jiangsu | 221000 | China |
|
| Yancheng First People's Hospital | Recruiting | Yancheng | Jiangsu | 224000 | China |
|
| ZhenJiang First People's Hospital | Recruiting | Zhenjiang | Jiangsu | 212002 | China |
|
| 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. |
| 23760676 | Background | 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. |
| 24974976 | Background | 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. |
| 25475080 | Background | 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. |
| 26202875 | Background | 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. |
| 29118007 | Background | 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. |
| ID | Term |
|---|---|
| D046248 | Pyloric Stenosis, Hypertrophic |
| ID | Term |
|---|---|
| D011707 | Pyloric Stenosis |
| D017219 | Gastric Outlet Obstruction |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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