A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma

February 4, 2026 updated by: Guangzhou Lupeng Pharmaceutical Company LTD.

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)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

394

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
        • Principal Investigator:
          • Zhigang Peng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A (Rocbrutinib)
Drug: Rocbrutinib
Rocbrutinib at 150 mg once daily orally until disease progression or unacceptable toxicity
Active Comparator: Arm B (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib)
Drug: Ibrutinib
Ibrutinib, 560 mg once daily orally and continuously
Drug: Acalabrutinib
Acalabrutinib, 100 mg twice daily orally and continuously
Drug: Zanubrutinib
Zanubrutinib, 160 mg twice daily orally and continuously
Drug: Orelabrutinib
Orelabrutinib, 150 mg once daily orally and continuously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS) assessed by IRC
Time Frame: approximately 30 months
approximately 30 months

Secondary Outcome Measures

Outcome Measure
Time Frame
PFS assessed by INV
Time Frame: approximately 30 months
approximately 30 months
Overall Response Rate (ORR) assessed by IRC and INV, respectively
Time Frame: Up to approximately 24 months
Up to approximately 24 months
Duration of Response (DOR) assessed by IRC and INV, respectively
Time Frame: approximately 30 months
approximately 30 months
Overall Survival
Time Frame: approximately 40 months
approximately 40 months
Number of participants with treatment-emergent adverse event as assessed by CTCAE v5.0
Time Frame: Up to approximately 40 months
Up to approximately 40 months
Number of participants with treatment-related adverse event as assessed by CTCAE v5.0
Time Frame: Up to approximately 40 months
Up to approximately 40 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Lupeng Pharmaceutical Company LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2026

Primary Completion (Estimated)

May 30, 2031

Study Completion (Estimated)

January 30, 2033

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP-168-CN302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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