Actively Recruiting
A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Led by Guangzhou Lupeng Pharmaceutical Company LTD. · Updated on 2026-02-06
394
Participants Needed
2
Research Sites
364 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Mantle cell lymphoma (MCL) is an aggressive yet often indolent type of B-cell non-Hodgkin lymphoma (NHL). Rocbrutinib (LP-168) is a novel, highly selective, fourth-generation Bruton's tyrosine kinase (BTK) inhibitor that exhibits both covalent (irreversible) and non-covalent (reversible) binding. This unique dual mechanism of action has shown promising efficacy and a favorable safety profile across various B-cell NHL subtypes in prior Phase 1 and 2 studies. This is a Phase 3, randomized, open-label study comparing Rocbrutinib versus investigator's choice of BTK inhibitor (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) in patients with MCL who have received at least one prior line of therapy and are naïve to BTK inhibitor treatment (except for intolerance).
CONDITIONS
Official Title
A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with mantle cell lymphoma and have received at least one prior systemic treatment with disease progression on the most recent therapy
- Have at least one measurable lymphoma lesion based on Lugano Response Criteria 2014
- ECOG Performance Status of 0 to 2
- Life expectancy of at least 12 weeks
- Adequate blood clotting, liver, kidney, and bone marrow function
- Recovery to Grade 1 or less from prior treatment side effects
- Use medically approved contraception if of childbearing potential and avoid sperm donation if male during the study
- Voluntarily agree to participate and follow the study plan and visit schedule
You will not qualify if you...
- Allergic or hypersensitive to Rocbrutinib or any control group drugs
- Previous treatment with any BTK-targeted therapy except for intolerance
- Lymphoma involvement in the central nervous system
- Other cancers diagnosed within the past 2 years (except certain cured skin and in situ cancers)
- Major heart problems within 6 months before study start
- Severe or uncontrolled systemic diseases or poor heart function
- Active uncontrolled infections including bacterial, fungal, viral, or tuberculosis
- Medical conditions that could affect drug absorption or study evaluations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Beijing Cancer hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Not Yet Recruiting
Research Team
Y
Yuqin Song
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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