drugset
drugset / Trial / NCT07199296

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

NCT07199296 ↗

Phase 2 Recruiting 45 enrolled Ruijin Hospital First Affiliated Hospital of Wenzhou Medical University · collabFujian Medical University Union Hospital · collabHuadong Hospital · collabQilu Hospital of Shandong University · collabThe First Affiliated Hospital of Anhui Medical University · collabThe Third Xiangya Hospital of Central South University · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-07-01
Primary completion
2028-07-01
Completion
2028-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Orelabrutinib Small molecule 150 mg Oral
Background Cytarabine Small molecule 200 mg/m2 Intravenous
Background Etoposide Small molecule 200 mg/m2 Intravenous
Background Melphalan Small molecule 140 mg/m2 Intravenous
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background carmustine Small molecule 300 mg/m2 Intravenous

Indications

mantle cell lymphoma