NCT06454968

Orelabrutinib Combined With Obinutuzumab and Lenalidomide (OGL Regimen) as First-line Treatment for Marginal Zone Lymphoma.

Orelabrutinib Combined With Obinutuzumab and Lenalidomide (OGL Regimen) as First-line Treatment for Marginal Zone Lymphoma：a Multicenter Prospective Single Arm Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with obinutuzumab and lenalidomide in untreated marginal zone lymphoma. The primary objective was the best complete response rate (CRR).

Detailed description

Marginal zone lymphomas (MZL) are a type of lymphoma that originates from the marginal zone tissue of the lymphoid follicles (Mucosa-associated lymphoid tissue, MALT), and include three subtypes: MALT lymphoma, nodal MZL, and splenic MZL. The incidence of MZL is second only to diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL), accounting for approximately 7.8% of all non-Hodgkin lymphomas (NHL). MZL is considered an indolent lymphoma, with patients generally having a better overall survival prognosis. Despite this, some patients still face the challenges of disease relapse or transformation into large cell lymphoma, leading to a poor prognosis. We conduct this prospective, phase II, single-arm clinical study to initially explore the efficacy and safety of Orelabrutinib combined with obinutuzumab and lenalidomide in patients with previously untreated marginal zone lymphoma. The patients will be treated with 6 cycles of OGL regimen. Patients with CR/PR after 6 cycles of OGL treatment will be treated with 6 cycles of single-agent orelabrutinib regimen.

Conditions

• Marginal Zone Lymphoma

Interventions

Type	Name	Description
DRUG	Orelabrutinib, obinutuzumab, lenalidomide	Orelabrutinib: 150mg qd d1-d21/C1-C6 obinutuzumab: 1000mg iv d1,d8,d15/c1, 1000mg iv d1/C2-C6 lenalidomide：25mg po qd d1-14/C1-C6 Orelabrutinib: 150mg qd d1-d28/C7-C12

Timeline

• Start date: 2024-06-20
• Primary completion: 2026-06-01
• Completion: 2028-06-01
• First posted: 2024-06-12
• Last updated: 2024-06-18

Locations

1 site across 1 country: China