NCT07257510

Pomalidomide Plus Orelabrutinib and Zuberitamab in Untreated Mantle Cell Lymphoma

A Prospective, Multicenter Clinical Study of Pomalidomide Combined With Orelabrutinib and Zuberitamab in Treatment-Naive Mantle Cell Lymphoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mantle Cell Lymphoma (MCL)
• POZ

Interventions

Type	Name	Description
DRUG	Pomalidomide	4mg/day PO once daily, day1-21/cycle
DRUG	Orelabrutinib	150mg/day PO once daily
DRUG	Zuberitamab	375 mg/m² IV on day 1/cycle
DRUG	Zuberitamab	375 mg/m² IV on day 1 of cycle 7, 10, 13, 16, 19 and 22,

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

1 site across 1 country: China