NCT07199296

Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment

A Prospective, Multicenter, Open-Label Clinical Study of Orelabrutinib in Combination With Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in Treatment-Naive, Non-High-Risk Mantle Cell Lymphoma (MCL)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, open-label, trial aims to evaluate the efficacy and safety of orelabrutinib in combination with rituximab with optional autologous hematopoietic stem cell transplantation in patients with non-high-risk mantle cell lymphoma (MCL). The primary objective is to assess the optimal complete response (CR) rate during the induction phase, with secondary objectives including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy.

Conditions

• Mantle Cell Lymphoma (MCL)

Interventions

Type	Name	Description
DRUG	Orelabrutinib	orelabrutinib 150mg/day PO once daily
DRUG	Rituximab (R)	rituximab 375 mg/m² IV on day 1, 8, 15, 22 in Cycle 1, then day 1/cycle
DRUG	BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan)	the reference doses are as follows (each center may adjust them as appropriate based on actual conditions): carmustine 300mg/m² IV d-1; etoposide 200mg/m² IV d-6-(-3); cytarabine 200mg/m² IV d-6-(-3); melphalan 140mg/m² IV d-2.
DRUG	orelabrutinib maintenance	orelabrutinib 150mg/day PO once daily

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2025-09-30
• Last updated: 2025-09-30

Locations

1 site across 1 country: China