RecruitingPhase 3NCT06496308

Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment

A Multicenter, Open-label, Randomized Controlled Study of Orelabrutinib in Combination With Bendamustine and Rituximab Versus Bendamustine and Rituximab in the Treatment of Transplant-Ineligible, Intermediate- to High-Risk Mantle Cell Lymphoma (MCL)


Sponsor

Ruijin Hospital

Enrollment

78 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This multicenter, open-label, randomized controlled trial aims to evaluate the efficacy and safety of Orelabrutinib in combination with Bendamustine and Rituximab (OBR) versus Bendamustine and Rituximab (BR) in patients with intermediate- to high-risk mantle cell lymphoma (MCL) who are ineligible for transplantation. The primary objective is to assess the 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: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding orelabrutinib (a BTK inhibitor) to the standard chemotherapy regimen of bendamustine and rituximab can improve outcomes for people newly diagnosed with mantle cell lymphoma — a rare and aggressive blood cancer. **You may be eligible if...** - You are 18 or older with a new diagnosis of mantle cell lymphoma confirmed by flow cytometry or biopsy - You have not received any prior treatment for this cancer - Your cancer is Stage II–IV (or Stage II requiring systemic treatment) - You are in reasonably good physical condition (ECOG 0–2) - You have at least one of the following high-risk features: high MIPI score, Ki67 above 50%, TP53 abnormality, or blastic/pleomorphic variant **You may NOT be eligible if...** - You have previously received treatment for mantle cell lymphoma - You have active brain involvement of your lymphoma - You have serious organ dysfunction, active infections, or autoimmune conditions - You are pregnant or breastfeeding 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 PO will be administered as per the schedule specified in the respective arm.

DRUGBendamustine

Bendamustine IV will be administered as per the schedule specified in the respective arm.

DRUGRituximab

Rituximab IV will be administered as per the schedule specified in the respective arm.

DRUGVenetoclax

Venetoclax PO will be administered as per the schedule specified in the respective arm.


Locations(1)

Ruijin Hospital

Shanghai, China

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NCT06496308


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