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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
394
Rocbrutinib at 150 mg once daily orally until disease progression or unacceptable toxicity
Ibrutinib, 560 mg once daily orally and continuously
Acalabrutinib, 100 mg twice daily orally and continuously
Zanubrutinib, 160 mg twice daily orally and continuously
Orelabrutinib, 150 mg once daily orally and continuously
Beijing Cancer hospital
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
NOT_YET_RECRUITINGProgression-free survival (PFS) assessed by IRC
Time frame: approximately 30 months
PFS assessed by INV
Time frame: approximately 30 months
Overall Response Rate (ORR) assessed by IRC and INV, respectively
Time frame: Up to approximately 24 months
Duration of Response (DOR) assessed by IRC and INV, respectively
Time frame: approximately 30 months
Overall Survival
Time frame: approximately 40 months
Number of participants with treatment-emergent adverse event as assessed by CTCAE v5.0
Time frame: Up to approximately 40 months
Number of participants with treatment-related adverse event as assessed by CTCAE v5.0
Time frame: Up to approximately 40 months
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