Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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)

A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma (NCT07377578) is a Phase 3 interventional studying Mantle Cell Lymphoma, sponsored by Guangzhou Lupeng Pharmaceutical Company LTD.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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).

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Mantle Cell Lymphoma, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 394 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form, and agrees to comply with the study treatment plan and visit schedule. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Rocbrutinib

Rocbrutinib at 150 mg once daily orally until disease progression or unacceptable toxicity

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

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Beijing Cancer hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07377578), the sponsor (Guangzhou Lupeng Pharmaceutical Company LTD.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07377578 clinical trial studying?

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, acalabruti… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07377578?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07377578?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07377578. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07377578. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.