Actively Recruiting
A Randomized, Open-label, Multicenter, Phase III Clinical Study Comparing Rocbrutinib Monotherapy Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL) (PRIME Study)
Led by Guangzhou Lupeng Pharmaceutical Company LTD. · Updated on 2026-02-06
394
Participants Needed
2
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Mantle cell lymphoma (MCL) is a type of B-cell non-Hodgkin lymphoma that can be aggressive or slow progressing. Researchers are evaluating Rocbrutinib, a new selective Bruton's tyrosine kinase (BTK) inhibitor with both irreversible and reversible binding, in comparison to other BTK inhibitors (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) for patients with relapsed or refractory MCL who have had at least one prior treatment and have not previously received BTK inhibitors except for intolerance. This study is a Phase 3, randomized, open-label trial aimed at assessing these treatments in this patient group. Participants will be randomly assigned to receive either Rocbrutinib at 150 mg once daily orally or one of the investigator's choice of BTK inhibitors, dosed continuously as per standard regimens (ibrutinib 560 mg once daily, acalabrutinib 100 mg twice daily, zanubrutinib 160 mg twice daily, or orelabrutinib 150 mg once daily). Treatment will continue until disease progression or unacceptable side effects occur. The study compares the effects of these treatments on disease control and safety. During the trial, participants will be monitored closely with assessments including progression-free survival evaluated by an independent review committee over about 30 months. Other measurements include overall response rates, duration of response, overall survival, and tracking of treatment-emergent and treatment-related adverse events for up to approximately 40 months. Participants will follow scheduled visits and evaluations to support safety and effectiveness monitoring throughout the study.
CONDITIONS
Brief 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 (MCL) who have received at least one prior systemic treatment and experienced disease progression on the latest therapy
- Have at least one measurable lesion according to Lugano Response Criteria 2014
- Have an ECOG Performance Status score of 0 to 2
- Have a life expectancy of at least 12 weeks
- Have adequate coagulation, liver, kidney, and bone marrow function
- Toxicities from previous anti-tumor therapy have recovered to Grade 1 or less per NCI CTCAE v5.0
- Male and female participants of childbearing potential agree to use medically approved contraception during the study; men must avoid sperm donation; women must be non-lactating and have a negative pregnancy test
- Voluntarily agree to participate, sign informed consent, and follow study treatment and visit schedule
You will not qualify if you...
- Known allergy or hypersensitivity to Rocbrutinib or any BTK inhibitor used in the study
- Previous treatment with any BTK inhibitor except if stopped due to intolerance
- Lymphoma involvement in the central nervous system
- History of other cancers within the last 2 years except certain cured skin or localized carcinomas
- Major cardiovascular events within 6 months before randomization
- Severe or uncontrolled systemic diseases or poor heart function as judged by the investigator
- Active uncontrolled infections including bacterial, fungal, viral, or tuberculosis
- Any medical condition that could affect drug absorption, metabolism, or study evaluation
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 - Until disease progression or unacceptable toxicity
Participants receive Rocbrutinib or one of the investigator's choice of BTK inhibitors daily until disease progression or unacceptable toxicity.
Regular visits for treatment and monitoring as scheduled by the study
Duration - Up to approximately 40 months
Participants are monitored for progression-free survival, overall response, overall survival, and adverse events after treatment ends.
Visits scheduled according to study protocol for safety and efficacy assessments
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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