drugset / Trial / NCT07257510

Pomalidomide Plus Orelabrutinib and Zuberitamab in Untreated Mantle Cell Lymphoma

NCT07257510

Recruiting 34 enrolled Peking University Third Hospital
NaSingle-groupOpen-labelTreatment

Summary

This multicenter trial evaluates the efficacy and safety of pomalidomide combined with orelabrutinib and zuberitamab (POZ) in patients with mantle cell lymphoma (MCL). After six cycles of POZ, patients who achieved minimal residual disease (MRD) negativity received maintenance therapy with orelabrutinib plus zuberitamab for up to 18 cycles. Those with MRD positivity were excluded and received alternative treatments. The primary endpoint is the MRD rate after six cycles of POZ. Secondary endpoints include progression-free survival (PFS), overall survival (OS), MRD rate, objective response rate (ORR), and safety.

Timeline

Start
2025-08-01
Primary completion
2028-08-01
Completion
2028-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Orelabrutinib Small molecule 150 mg Oral
Subject Pomalidomide Other / unclassified 4 mg Oral
Subject Zuberitamab Monoclonal antibody 375 mg/m2 Intravenous

Indications