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

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

Trial Details

NCT ID
NCT07377578
Phase
PHASE3
Sponsor
Guangzhou Lupeng Pharmaceutical Company LTD.
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Rocbrutinib
  • Ibrutinib
  • Acalabrutinib
  • Zanubrutinib
  • Orelabrutinib
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Nanning, Guangxi, China|22.81667,108.31667

Key Eligibility 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 t…
  • 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.

For full eligibility, visit ClinicalTrials.gov.

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