Actively Recruiting
Orelabrutinib Plus Lisaftoclax and Rituximab in Untreated Mantle Cell Lymphoma With High-Risk Disease
Led by Ruijin Hospital · Updated on 2025-12-09
25
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
F
Fujian Medical University Union Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Orelabrutinib Plus Lisaftoclax and Rituximab in Untreated Mantle Cell Lymphoma With High-Risk Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with mantle cell lymphoma (MCL) by flow cytometry or histopathology and has not received prior treatment
- Age greater than 14 years, any gender
- Ann Arbor stage II to IV; stage II patients must require systemic therapy based on investigator judgment
- At least one measurable lesion
- Presence of at least one high-risk factor: MIPI score 6-11, Ki-67 over 30%, TP53 mutation or loss or p53 protein expression over 50%, blastoid or pleomorphic variant
- Laboratory tests meet requirements: white blood cell count ≥ 3.0 x 10^9/L, absolute neutrophil count ≥ 1.5 x 10^9/L, hemoglobin ≥ 90 g/L, platelet count ≥ 75 x 10^9/L; liver transaminases ≤ 2.5 times upper limit normal, bilirubin ≤ 1.5 times upper limit normal; serum creatinine 44-133 mmol/L
- Investigator estimates life expectancy over 12 weeks from screening
- Willing and able to participate in all required study assessments and procedures
You will not qualify if you...
- Previous treatment with BTK inhibitors
- Severe complications or serious infections
- Uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, or serious infectious diseases
- Active infections needing systemic treatment, including bacterial, fungal, or viral infections
- HIV infection
- Mental disorders or inability to comply fully with the study protocol
- Any other conditions deemed unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
L
Li Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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