OncoMatch/Clinical Trials/NCT06496308
Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
Is NCT06496308 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
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)
Demographics
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.
Frequently asked questions
Is NCT06496308 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage II or III or IV is required.
Is there an age limit?
Yes. Patients must be 80 years or younger.
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 qualifyRelated pages