RecruitingPhase 3NCT07377578

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)


Sponsor

Guangzhou Lupeng Pharmaceutical Company LTD.

Enrollment

394 participants

Start Date

Feb 5, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares rocbrutinib, a new targeted drug, against existing BTK inhibitor drugs (a standard type of treatment) in patients with relapsed or treatment-resistant mantle cell lymphoma — a type of blood cancer. **You may be eligible if...** - You have been diagnosed with mantle cell lymphoma - You have received at least one prior treatment and your disease has progressed - You have at least one measurable lesion on imaging - Your general health status is adequate (ECOG 0–2) - Your life expectancy is at least 12 weeks - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You are allergic to rocbrutinib or to the comparator drugs in the study - You have previously received any BTK-targeted therapy (unless you had to stop due to intolerance) - Your lymphoma has spread to the brain or spinal cord - You have had another cancer within the past 2 years (with limited exceptions) - You have had major heart events in the past 6 months - You have uncontrolled infections or serious systemic illnesses Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRocbrutinib

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

DRUGIbrutinib

Ibrutinib, 560 mg once daily orally and continuously

DRUGAcalabrutinib

Acalabrutinib, 100 mg twice daily orally and continuously

DRUGZanubrutinib

Zanubrutinib, 160 mg twice daily orally and continuously

DRUGOrelabrutinib

Orelabrutinib, 150 mg once daily orally and continuously


Locations(2)

Beijing Cancer hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

View Full Details on ClinicalTrials.gov

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NCT07377578


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