OncoMatch/Clinical Trials/NCT07272499
Orelabrutinib Plus Lisaftoclax and Rituximab in Untreated Mantle Cell Lymphoma With High-Risk Disease
Is NCT07272499 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Orelabrutinib and Rituximab (R) for mantle cell lymphoma (mcl).
Treatment: Orelabrutinib · Rituximab (R) · Lisaftoclax (APG-2575) · Lisaftoclax (APG-2575) — This multicenter, open-label, trial aims to evaluate the efficacy and safety of orelabrutinib plus lisaftoclax and rituximab in patients with 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Other
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Allowed: TP53 mutation
TP53 mutation/loss or p53 protein expression >50%
Allowed: TP53 loss
TP53 mutation/loss or p53 protein expression >50%
Allowed: TP53 p53 protein expression >50%
TP53 mutation/loss or p53 protein expression >50%
Disease stage
Required: Stage II, III, IV
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 NCT07272499 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.
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