Actively Recruiting
Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment
Led by Ruijin Hospital · Updated on 2025-09-30
45
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 in combination with rituximab with optional autologous hematopoietic stem cell transplantation in patients with non-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 and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with mantle cell lymphoma (MCL) by flow cytometry or histopathology, with no prior treatment
- Aged over 14 years, any gender
- Ann Arbor stage II to IV; stage II patients must require systemic therapy as judged by the investigator
- At least one measurable lesion
- Blood tests showing: white blood cell count ≥3.0×10^9/L, absolute neutrophil count ≥1.5×10^9/L, hemoglobin ≥90 g/L, platelet count ≥75×10^9/L
- Liver function tests with transaminases ≤2.5 times and bilirubin ≤1.5 times the upper limit of normal
- Serum creatinine between 44 and 133 mmol/L
- Life expectancy greater than 12 weeks as judged by the investigator
- Willingness and ability to participate in all study assessments and procedures
You will not qualify if you...
- Previous treatment with BTK inhibitors
- Presence of any high-risk factors: MIPI score 6-11, Ki67 > 30%, TP53 abnormality, blastic or pleomorphic variation
- Severe complications or serious infections
- Uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, or serious infectious diseases
- Active infections requiring systemic treatment, including bacterial, fungal, or viral infections
- HIV infection
- Mental disorders or inability to comply fully with the study protocol
- Other conditions judged by the investigator as unsuitable for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, 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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