Actively Recruiting
Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
Led by Ruijin Hospital · Updated on 2024-07-11
78
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
T
The Third Xiangya Hospital of Central South University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with mantle cell lymphoma confirmed by flow cytometry or histopathology, with no prior treatment
- Age between 18 and 80 years, both genders eligible
- Ann Arbor stage II-IV; stage II patients must require systemic therapy as judged by the investigator
- At least one measurable lesion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Presence of at least one high-risk factor: MIPI score 4-11, Ki67 over 50%, TP53 abnormality, or blastic/pleomorphic variation
- Not suitable candidates for autologous hematopoietic stem cell transplantation
- Laboratory values meeting: white blood cell count ≥3.0x10^9/L, absolute neutrophil count ≥1.5x10^9/L, hemoglobin ≥90 g/L, platelet count ≥75x10^9/L; transaminases ≤2.5 times upper limit; bilirubin ≤1.5 times upper limit; serum creatinine 44-133 mmol/L
- Life expectancy greater than 12 weeks from screening
- Willing and able to participate in all required study assessments and procedures
You will not qualify if you...
- Prior treatment with BTK inhibitors
- Presence of 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 fully comply with study protocol
- Any other condition judged by the investigator as unsuitable for study 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
W
Weili Zhao
CONTACT
L
Li Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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