OncoMatch/Clinical Trials/NCT06496308
Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
Is NCT06496308 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Orelabrutinib and Bendamustine for mantle cell lymphoma (mcl).
Treatment: Orelabrutinib · Bendamustine · Rituximab · Venetoclax — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Allowed: TP53 abnormality
Any one of the following high-risk factors is present: ... TP53 abnormality
Allowed: MKI67 overexpression
Any one of the following high-risk factors is present: ... Ki67 > 50%
Disease stage
Required: Stage II, III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: btk inhibitor
Lab requirements
Blood counts
white blood cell count ≥3.0×10^9/l, absolute neutrophil count ≥1.5×10^9/l, hemoglobin ≥90g/l, platelet count ≥75×10^9/l
Kidney function
serum creatinine 44-133 mmol/l
Liver function
transaminases ≤2.5 times the upper limit of normal, bilirubin ≤1.5 times the upper limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify