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

Sponsor
Guangzhou Lupeng Pharmaceutical Company LTD.
Study ID
NCT07377578
Phase
PHASE3
Status
Recruiting
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Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rocbrutinib — DRUG
    Rocbrutinib at 150 mg once daily orally until disease progression or unacceptable toxicity
  • Ibrutinib — DRUG
    Ibrutinib, 560 mg once daily orally and continuously
  • Acalabrutinib — DRUG
    Acalabrutinib, 100 mg twice daily orally and continuously
  • Zanubrutinib — DRUG
    Zanubrutinib, 160 mg twice daily orally and continuously
  • Orelabrutinib — DRUG
    Orelabrutinib, 150 mg once daily orally and continuously

Study Details

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).

Key Dates

Start date
Feb 5, 2026
Status verified
Feb 2026
Primary completion
May 30, 2031
Completion
Jan 30, 2033

Study Design

Enrollment
394 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (Rocbrutinib)
  • Active Comparator: Arm B (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib)

Primary Outcome Measure

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

Central Contacts

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