RecruitingPhase 2NCT07199296

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)


Sponsor

Ruijin Hospital

Enrollment

45 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment for newly diagnosed mantle cell lymphoma (MCL) — a type of blood cancer — using two drugs (orelabrutinib and rituximab), with the option of a stem cell transplant for eligible patients. The goal is to evaluate how well this combination controls the cancer. **You may be eligible if...** - You are over 14 years old with a confirmed diagnosis of mantle cell lymphoma - You have not previously received treatment for this cancer - You have measurable disease in at least one location - Your blood counts and liver and kidney function meet the required thresholds **You may NOT be eligible if...** - You have already received treatment for mantle cell lymphoma - Your blood counts, liver function, or kidney function are below acceptable levels - You have serious cardiovascular or other health conditions that would make treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOrelabrutinib

orelabrutinib 150mg/day PO once daily

DRUGRituximab (R)

rituximab 375 mg/m² IV on day 1, 8, 15, 22 in Cycle 1, then day 1/cycle

DRUGBEAM (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.

DRUGorelabrutinib maintenance

orelabrutinib 150mg/day PO once daily


Locations(1)

Ruijin Hospital

Shanghai, China

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NCT07199296


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