NCT05182957

Clinical Study on Anti-PD-1 Plus Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma

Clinical Study on the Efficacy and Safety of Anti-PD-1 Monoclonal Antibody Combined Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aim of this study will evaluate the Efficacy and Safety of Anti-PD-1 monoclonal antibody Combined Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma Patients.

Detailed description

Peripheral T-cell lymphomas (PTCLs) are malignancies of immunologically mature T-cells that arise in peripheral lymphoid tissues. Compared with B-cell lymphoma, the treatment methods of PTCL are more limited, the first-line therapy is usually CHOP-like therapy, but the efficacy is poor, 5-year overall survival rate (OS) is only 30%-40%. Anti-PD-1 monoclonal antibody, Lenalidomide and Azacitidine can all have tumor-killing effects, and the three have complementary theoretical basis in the mechanism of action. This study will evaluate the efficacy and safety of Anti-PD-1 monoclonal antibody Combined Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma patients.

Conditions

• Relapsed/Refractory Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Anti-PD-1 monoclonal antibody	Anti-PD-1 monoclonal antibody, 200mg i.v d1 (/21d)
DRUG	Lenalidomide	Lenalidomide 25mg qd po d1-d10 (/21d)
DRUG	Azacitidine	Azacitidine 75mg/m2 i.v d1-d7 (/21d)

Timeline

• Start date: 2022-12-14
• Primary completion: 2023-12-14
• Completion: 2023-12-14
• First posted: 2022-01-10
• Last updated: 2023-01-31

Locations

1 site across 1 country: China