Canceled by the investigator. A phase II trial of PD-1 inhibitor in combination with GemOx in patients with relapsed/refractory EBV-positive diffuse large B-cell lymphoma

A study on the safety and efficacy of the combination of tislelizumab and GemOx regimen (gemcitabine and oxaliplatin) for the treatment of relapsed/refractory EBV-positive diffuse large B-cell lymphoma.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300076513

Enrollment

Unknown

Registered

2023-10-10

Start date

2023-11-01

Completion date

Unknown

Last updated

2024-01-28

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

Conditions

EBV-positive diffuse large B-cell lymphoma (EBV+ DLBCL)

Interventions

Experimental group:Tislelizumab + GemOx ± rituximab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Histopathologically confirmed diffuse large B-cell lymphoma (DLBCL), and EBER positive ; 2.Relapsed/refractory status following 1 or more prior systemic therapies; 3.Age = 18 years; 4.At least one measurable lesion (Lymph node lesions: long diameter >= 1.5 cm; extranodal lesions: long diameter >= 1.0 cm); 5.ECOG performance status 0-3; 6.Life expectancy > 3 months; 7.Adequate bone marrow, renal, and hepatic function: (1)ANC > 1.5×109/L(unless there is bone marrow infiltration by lymphoma); (2)PLT > 50×109/L (unless there is bone marrow infiltration by lymphoma); (3)Hb > 70g/L (unless there is bone marrow infiltration by lymphoma); (4)Bilirubin < 2 times ULN (unless attributed to lymphoma); (5)Transaminases < 3 times ULN (unless attributed to lymphoma); (6)Serum creatinine < 2 times ULN (unless attributed to lymphoma).

Exclusion criteria

Exclusion criteria: 1.CNS or meningeal involvement by lymphoma; 2.Pulse oximetry <93% on room air; 3.Symptomatic congestive heart failure (NYHA class III or IV), unstable angina pectoris, or dysrhythmias; 4.History of severe hypersensitivity reaction to monoclonal antibodies; 5.Has history of interstitial lung disease or non-infectious pneumonitis or has evidence of interstitial lung disease or non infectious pneumonitis currently; 6.History of autoimmune disorders (with the exception of hypothyroidism, type 1 diabetes, vitiligo, alopecia); 7.History of solid organ transplant; 8.Serious acute or chronic infection requiring systemic therapy; 9.Known HIV infection; 10.Active hepatitis B or C infection; 11.Pregnant or lactating patients; 12.Patient not suitable to participate in this clinical trial in the opinion of the investigator.

Design outcomes

Primary

Measure	Time frame
Overall response rate;	—

Secondary

Measure	Time frame
Complete remission rate;Progression-free survival;Overall survival;Duration of response;Safety;	—

Countries

China

Contacts

Public ContactYanli Lai

First Affiliated Hospital of Ningbo University

2452146178@qq.com+86 158 5186 6197

Outcome results

None listed

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