EBV-Positive DLBCL, NosPhase 2NCT04181489
Sintilimab in Combination With R-CHOP in Patients With Treatment-naive EBV-positive DLBCL, NOS
A Phase 2 study testing Sintilimab, Rituximab and Cyclophosphamide in people with EBV-Positive DLBCL, Nos, run by The First Affiliated Hospital with Nanjing Medical University at 11 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- EBV-Positive DLBCL, Nos
- What is being tested?
- Sintilimab, Rituximab and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 11 sitesChina
- Study dates
- 1 Jan 2019to 30 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- Hepatic function: total bilirubin less than 1.5-fold of upper normal level; ALT and AST less than 2-fold of upper normal level.
- Renal function: Serum creatine less than 1.5-fold of upper normal level or Ccr ≥ 50 mL/min.
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- Cardiac function: New York Heart Association class II or below (EF≥ 50% according to TDE)
- 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;
- 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.
Who cannot join
- CNS or meningeal involvement;
- 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;
- Known sensitivity or allergy to investigational product;
- 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;
- Previous allogeneic organ transplantation or allogeneic stem cell transplantation;
- Intention to use any other anti-tumour therapy during treatment;
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- Use of systemic anti-tumour treatment within 3 months before first dose of study regimen;
- Active and severe infectious diseases requiring systemic treatment;
- 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)
- 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.
- Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected persons;
- Previous history of Idiopathic pulmonary fibrosis or Idiopathic pneumonia;
- Active tuberculosis;
- Presence of ≥ Grade 3 immune therapy related toxicity;
- History of mental disorder including epilepsia and dementia;
- Any anti-infectious vital vaccine usage 4 weeks before the first dose or during treatment;
- Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment;
- Women who are pregnant or lactating.
- Usage of other experimental drugs within 1 month before treatment;
- In any conditions which investigator considered ineligible for this study
Trial locations and contacts
11 sites in 1 country.
Wei Xu, M.D., Ph.D. contact
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
ChangZhou First People's Hospital
Changzhou, Jiangsu, 213003
XiangShan Cao, M.D., Ph.D.
XiangShan Cao, M.D., Ph.D.
- Recruiting
ChangZhou No.2 People's Hospital
Changzhou, Jiangsu, 213011
Min Zhou, Dr.
Min Zhou, M.D.
- Recruiting
HuaiAn First People's Hospital
HuaiAn, Jiangsu, 223300
Liang Yu, Dr.
Liang Yu, M.D., Ph.D.
- Recruiting
Drum tower hospital
Nanjing, Jiangsu, 210000
Jingyan Xu, M.D., Ph.D.
- Recruiting
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Nanjing, Jiangsu, 21002
Yi Xia, M.D., Ph.D., +86 25 68136034, cynthia0311@163.com
Wei Xu, M.D., Ph.D.
- Recruiting
The First Affiliated Hospital Of Nantong University
Nantong, Jiangsu, 226000
Wenyu Shi, M.D., Ph.D.
- Recruiting
The Second Affiliated Hospital Of Suzhou University
Suzhou, Jiangsu, 215000
Bingzong Li, M.D., Ph.D.
- Recruiting
WuXi People's Hospital
Wuxi, Jiangsu, 214023
Yun Zhuang, M.D.
YunFeng Shen, M.D., Ph.D.
- Recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000
Xiaolin Li, M.D., Ph.D.
- Recruiting
Yancheng First People's Hospital
Yancheng, Jiangsu, 224000
Hao Xu, M.D., Ph.D.
- Recruiting
ZhenJiang First People's Hospital
Zhenjiang, Jiangsu, 212002
Yan Zhu, Dr.
Yan Zhu, M.D., Ph.D.
About this study
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
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.
- Conditions
- EBV-Positive DLBCL, Nos
- Being tested
- Sintilimab, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
- Keywords
- Sintilimab, R-CHOP, EBV-Positive DLBCL, nos, treatment-naive
- Medical subject headings
- Pyloric Stenosis, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Sintilimab 200mg d0
RituximabDrug
Rituximab 375 mg/m2 d0
CyclophosphamideDrug
Cyclophosphamide 750 mg/m2 d1
DoxorubicinDrug
Doxorubicin 50 mg/m2 d1
VincristineDrug
Vincristine 1.4mg/m2 (maximum 2mg) d1
PrednisoloneDrug
Prednisolone 60mg/m2 d1-5
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab + R-CHOP | Experimental | Not described Receives: Drug: Sintilimab; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive free survival
from date of inclusion to date of progression, relapse, or death from any cause
Measured: 2 years
Secondary outcomes (3)
Overall response rate
overall response rate after treated by Sintilimab and R-CHOP
Measured: 6 months
Overall survival
from the date of inclusion to date of death, irrespective of cause
Measured: 2 years
Incidence of treatment related adverse events as assessed by NCI-CTCAE 5.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start1 Jan 2019
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for EBV-Positive DLBCL, NosStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WEI XU, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Wei Xu, M.D., Ph.D., Principal investigator, The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181489
- Sponsor's protocol ID
- 2019-SR-271
- Status last verified
- Nov 2019
- First submitted
- 24 Nov 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26980727Coiffier 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.
PubMed 20548096Ahn 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.
PubMed 23760676Sato 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.
PubMed 24974976Hong 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.
PubMed 25475080Lu 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.
PubMed 26202875Xu-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.
PubMed 29118007
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04181489
- Acronym / sponsor ID
- 2019-SR-271
- Conditions
- EBV-Positive DLBCL, Nos
- Keywords
- Sintilimab, R-CHOP, EBV-Positive DLBCL, nos, treatment-naive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 29 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab + R-CHOP | Experimental | Drug: Sintilimab, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisolone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
- Hepatic function: total bilirubin less than 1.5-fold of upper normal level; ALT and AST less than 2-fold of upper normal level.
Key exclusion criteria (20 listed)
- CNS or meningeal involvement;
- 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;
- Known sensitivity or allergy to investigational product;
- 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;
- Previous allogeneic organ transplantation or allogeneic stem cell transplantation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SintilimabSintilimab 200mg d0 | Drug | Sintilimab + R-CHOP |
| RituximabRituximab 375 mg/m2 d0 | Drug | Sintilimab + R-CHOP |
| CyclophosphamideCyclophosphamide 750 mg/m2 d1 | Drug | Sintilimab + R-CHOP |
| DoxorubicinDoxorubicin 50 mg/m2 d1 | Drug | Sintilimab + R-CHOP |
| VincristineVincristine 1.4mg/m2 (maximum 2mg) d1 | Drug | Sintilimab + R-CHOP |
| PrednisolonePrednisolone 60mg/m2 d1-5 | Drug | Sintilimab + R-CHOP |
Primary outcome
Progressive free survival
Time frame: 2 years
from date of inclusion to date of progression, relapse, or death from any cause
3 secondary outcomes
Overall response rate
Time frame: 6 months
Overall survival
Time frame: 2 years
Incidence of treatment related adverse events as assessed by NCI-CTCAE 5.0
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Background: PubMed 26980727Swerdlow 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.
- Background: PubMed 20548096Coiffier 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.
- Background: PubMed 23760676Ahn 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.
- Background: PubMed 24974976Sato 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.
- Background: PubMed 25475080Hong 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.
- Background: PubMed 26202875Lu 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.
- Background: PubMed 29118007Xu-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Xu, M.D., Ph.D. contact
Wei Xu, M.D., Ph.D. principal investigator
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab, Rituximab and Cyclophosphamide in people with EBV-Positive DLBCL, Nos, run by The First Affiliated Hospital with Nanjing Medical University at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yi xia, M.D., Ph.D. (025-68306034, cynthia0311@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progressive free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04181489, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.