NCT04860674

A Prospective Study of PD-1 Inhibitor Combined With ICE in the Treatment of Relapsed/Refractory Gray Area Lymphoma

A Prospective, Single-arm, Phase II Study of PD-1 Inhibitor Combined With Ifosfamide, Carboplatin, and Etoposide (ICE) in the Treatment of Relapsed/Refractory Gray Area Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

There are no standard chemotherapy regimens for relapse/refractory gray area lymphoma. The programmed cell death ligand 1 (PD-L1) encoding gene is located in 9p24.1, so it is speculated that the programmed cell death pathway plays an important role in gray area lymphoma formation by evading immune surveillance in GZL.The purpose of this study was to evaluate the efficacy and safety of PD-1 monoclonal antibody combined with ICE in the treatment of patients with relapsed/refractory gray area lymphoma.

Detailed description

The purpose of this study was to evaluate the efficacy and safety of PD-1 monoclonal antibody combined with ICE in the treatment of patients with relapsed/refractory gray zone lymphoma. The main study endpoint is the Objective Response Rate (ORR), including Complete Remission Rate (CRR) and Partial Remission Rate (PRR), was evaluated according to Lugano2014 lymphoma efficacy evaluation criteria.

Conditions

• Gray Zone Lymphoma
• Relapse/Recurrence
• Chemotherapy Effect

Interventions

Type	Name	Description
DRUG	PD-1 inhibitor +ICE	PD-1 inhibitor (tirelizumab) combined with ifosfamide, carboplatin and etoposide (ICE) regimen

Timeline

• Start date: 2021-05-01
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2021-04-27
• Last updated: 2021-04-27