NCT05816746

Decitabine and Anti-PD-1 in R/R DLBCL

Low-Dose Decitabine Plus Anti-PD-1 Treatment for Relapsed/Refractory Diffuse Large B Cell Lymphoma With Extranodal (Esp. Central Nervous System) Involvement: A PhaseⅡClinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Patients with relapsed/refractory diffuse large B cell lymphoma with extranodal (esp. central nervous system) involvement treated with Low-Dose Decitabine plus anti-PD-1 regimen. 3 weeks for a cycle, with a total of 2 years or until the disease progress esor unacceptable toxicity occurs, or the patient decides to withdraw from the trial.

Detailed description

To evaluate the effectiveness and safety of patients with relapsed/refractory diffuse large B cell lymphoma with extranodal (esp. central nervous system) involvement treated with Low-Dose Decitabine plus anti-PD-1 regimen. 3 weeks for a cycle, with a total of 2 years or until the disease progress esor unacceptable toxicity occurs, or the patient decides to withdraw from the trial. Enrollment was planned to be completed within 2 years, and all trials were followed up for 12 months after the last enrolled patient completed treatment. All cases will be followed up and the long-term curative effect will be observed and recorded.

Conditions

• Diffuse Large B Cell Lymphoma
• Relapse/Recurrence
• Extranodal Extension
• Central Nervous System Lymphoma

Interventions

Type	Name	Description
DRUG	Low-Dose Decitabine plus anti-PD-1	Decitabine 10mg/d，VD d1-5; PD-1 200mg，d8

Timeline

• Start date: 2023-05-15
• Primary completion: 2025-03-01
• Completion: 2026-03-01
• First posted: 2023-04-18
• Last updated: 2023-05-09

Locations

1 site across 1 country: China