Actively Recruiting
Orelabrutinib with Bendamustine and Rituximab Versus Bendamustine and Rituximab in Transplant-Ineligible Intermediate- to High-Risk Mantle Cell Lymphoma
Led by Ruijin Hospital · Updated on 2024-07-11
78
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the safety and effectiveness of Orelabrutinib combined with Bendamustine and Rituximab (OBR) compared to Bendamustine and Rituximab (BR) alone in patients with intermediate- to high-risk mantle cell lymphoma (MCL) who cannot undergo transplantation. This phase 3, multicenter, open-label, randomized controlled trial aims to measure the complete response rate during the induction phase. Secondary goals include progression-free survival, overall survival, objective response rate, and investigating how tumor biomarkers relate to treatment effects. During the induction phase, participants are randomly assigned to one of two groups: the OBR group receives rituximab and bendamustine by intravenous infusion plus daily oral Orelabrutinib for six 28-day cycles; the BR group receives rituximab and bendamustine without Orelabrutinib for the same duration. In the maintenance phase, treatment depends on specific genetic markers and disease variants. Patients with TP53 mutation or blastic/pleomorphic variants receive daily Orelabrutinib and gradually increased Venetoclax doses for up to two years. Those without these markers receive daily Orelabrutinib alone for up to two years. Participants will undergo regular assessments including blood tests, imaging, and physical exams to monitor treatment response and safety. Researchers will measure complete response rates about 6 to 8 weeks after induction treatment ends and track progression-free and overall survival for up to two years. Study involvement includes scheduled visits for treatment administration and evaluation, with ongoing monitoring for side effects and disease status throughout the trial duration.
CONDITIONS
Brief 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 (MCL) by flow cytometry or histopathology and have not received prior treatment
- Aged 18 to 80 years, any gender
- Ann Arbor stage II-IV; stage II patients must require systemic therapy as judged by the investigator
- Have at least one measurable lesion
- Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 2
- Presence of at least one high-risk factor: MIPI score 4-11, Ki67 over 50%, TP53 abnormality, blastic or pleomorphic variant
- Not suitable candidates for autologous hematopoietic stem cell transplantation
- Meet blood, liver, and kidney function requirements specified in the protocol
- Life expectancy over 12 weeks as judged by the investigator
- Willing and able to participate in all required study assessments and procedures
You will not qualify if you...
- Prior treatment with BTK inhibitors
- Severe complications or serious infections
- Uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, or serious infections
- 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 to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 cycles of 28 days each
Participants receive either a combination of Orelabrutinib, Bendamustine, and Rituximab or Bendamustine and Rituximab alone in an induction phase consisting of 6 cycles. Each cycle lasts 28 days. Orelabrutinib is taken orally daily, while Bendamustine and Rituximab are given intravenously on specific days of each cycle.
6 treatment cycles with multiple visits per cycle for drug administration
Duration - Up to 2 years
After induction, participants receive maintenance treatment for up to 2 years. Those with TP53 mutation or blastic/pleomorphic variants receive daily oral Orelabrutinib plus Venetoclax with a gradual dose escalation to a target dose. Participants without these variants receive daily oral Orelabrutinib alone.
Regular follow-up visits during maintenance treatment
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, China, 200025
Actively Recruiting
Research Team
W
Weili Zhao
L
Li Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here