A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma
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)
1 other identifier
interventional
394
1 country
2
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2026
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2026
CompletedFirst Posted
Study publicly available on registry
January 30, 2026
CompletedStudy Start
First participant enrolled
February 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 30, 2033
February 6, 2026
February 1, 2026
5.3 years
January 13, 2026
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS) assessed by IRC
approximately 30 months
Secondary Outcomes (6)
PFS assessed by INV
approximately 30 months
Overall Response Rate (ORR) assessed by IRC and INV, respectively
Up to approximately 24 months
Duration of Response (DOR) assessed by IRC and INV, respectively
approximately 30 months
Overall Survival
approximately 40 months
Number of participants with treatment-emergent adverse event as assessed by CTCAE v5.0
Up to approximately 40 months
- +1 more secondary outcomes
Study Arms (2)
Arm A (Rocbrutinib)
EXPERIMENTALArm B (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib)
ACTIVE COMPARATORInterventions
Rocbrutinib at 150 mg once daily orally until disease progression or unacceptable toxicity
Ibrutinib, 560 mg once daily orally and continuously
Acalabrutinib, 100 mg twice daily orally and continuously
Zanubrutinib, 160 mg twice daily orally and continuously
Orelabrutinib, 150 mg once daily orally and continuously
Eligibility Criteria
You may qualify if:
- Diagnosed with MCL, who have received at least one prior systemic regimen(s), and have experienced disease progression on the most recent line of therapy.
- Have at least one measurable lesion according to the Lugano Response Criteria 2014.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2.
- Life expectancy ≥ 12 weeks.
- Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function, etc.
- Toxicities or complications from prior anti-tumor therapy have recovered to Grade ≤1 according to NCI CTCAE v5.0.
- All male subjects and female subjects of childbearing potential must strictly use medically approved contraception throughout the entire study period. All male subjects must also avoid sperm donation during the above period. For women of childbearing potential, the result of serum pregnancy test must be obtained. Women must be non-lactating.
- Subject voluntarily enrolls and signs the informed consent form, and agrees to comply with the study treatment plan and visit schedule.
You may not qualify if:
- Hypersensitivity to Rocbrutinib or any study drug in the control group.
- Prior treatment with any BTK-targeted therapy (except for intolerance).
- Central nervous system (CNS) involvement by lymphoma.
- History of other malignancy (except MCL) within the past 2 years, excluding radically cured skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, localized squamous cell carcinoma, etc.
- History of major cardiovascular events within 6 months prior to randomization.
- Presence of any severe and/or uncontrolled systemic disease that, in the investigator's judgment, or have poor cardiac function.
- Uncontrolled active bacterial, fungal, or viral systemic infection, or active tuberculosis infection.
- Any medical condition that could interfere with the absorption, distribution, metabolism, or excretion (ADME) of the investigational drug or the evaluation of study outcomes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beijing Cancer hospital
Beijing, Beijing Municipality, 100142, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2026
First Posted
January 30, 2026
Study Start
February 5, 2026
Primary Completion (Estimated)
May 30, 2031
Study Completion (Estimated)
January 30, 2033
Last Updated
February 6, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share