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RECRUITING
NCT07199296
PHASE2

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

14 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2025-07-01

Completion Date

2028-07-01

Last Updated

2025-09-30

Healthy Volunteers

No

Interventions

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

Locations (1)

Ruijin Hospital

Shanghai, China