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

NCT07377578 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2026-02-06

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Guangzhou Lupeng Pharmaceutical Company LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-05
Primary Completion
2031-05-30
Completion
2033-01-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07377578 on ClinicalTrials.gov