A prospective clinical study of the treatment with PD-1 Inhibitor Sintilimab in relapse/refractory EBV-related hemophagocytic syndrome and chronic active EBV infection, and mechanism study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000040193

Enrollment

Unknown

Registered

2020-11-25

Start date

2020-11-23

Completion date

Unknown

Last updated

2021-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EBV-associated Lymphoproliferative Disease

Interventions

EBV-HLH:Sintilimab 100mg ivgtt every 4 weeks

CAEBV infection:Sintilimab 100mg ivgtt every 4 weeks

Eligibility

Sex/Gender

All

Age

14 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. aged 14-70 years old male or female. 2. In accordance with the diagnostic criteria for relapsed/refractory CAEBV or EBV-HLH: (1) Relapsed/Refractory CAEBV: 1) recurrent or consistent IM-like symptoms for at least 3 months; 2) find EBER+ cells in tissue or plasma EBV-DNA > 10^2 copies/ml. (2) Relapsed/Refractory EBV-HLH: 1) meet the criteria of HLH-2004 and plasma EBV-DNA > 10^2 copies/ml; 2) no response to standard ED regimen; 3) total clinical course >3 month; 3. Without other uncontrollable infection; 4. No seizure for at least 4 weeks for CNS involved patients. 5. HBVsAg(-) patients, or undergoing anti-HBV treatment for HBVsAg(+) patients; 6. HIV(-); 7. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Primary HLH; 2. Tumor-related HLH; 3. Patients with autoimmune Disease, undergoing steroid or immunosuppressor agent treatment; 4. After HSCT; 5. Pregnancy or lactating Women; 6. Allergic to PD-1 inhibitor; 7. Patients with severe heart, lung and kidney disease; 8. Active digestive tract bleeding; 9. With uncontrolled bacterial/fungal infection.

Design outcomes

Primary

Measure	Time frame
Clinical Response Rate;Time to Obtain Complete Clinical Response;Change of Plasma and Intracellular EBV-DNA after Treatment;Overall Survival;Progression Free Survival;	—

Secondary

Measure	Time frame
Change of Laboratory Markers after Treatment;Epidemiology Characteristics of EBV-LPDs;	—

Countries

China

Contacts

Public ContactTing Liu

West China Hospital, Sichuan University

liuting@scu.edu.cn+86 18980601240

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026