A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Rocbrutinib: Rocbrutinib at 150 mg once daily orally until disease progression or unacceptable toxicity
Ibrutinib: Ibrutinib, 560 mg once daily orally and continuously
Acalabrutinib: Acalabrutinib, 100 mg twice daily orally and continuously
Zanubrutinib: Zanubrutinib, 160 mg twice daily orally and continuously
Orelabrutinib: Orelabrutinib, 150 mg once daily orally and continuously
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).
Eligibility
Primary outcome measure(s)
- Progression-free survival (PFS) assessed by IRC — approximately 30 months
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Cancer hospital | Beijing | Beijing Municipality | Recruiting |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | Not Yet Recruiting |
On this site
📄 Imbruvica (ibrutinib) drug profile → 📄 Calquence (acalabrutinib) drug profile → 📄 Brukinsa (zanubrutinib) drug profile →More Guangzhou Lupeng Pharmaceutical Company LTD. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07377578 on ClinicalTrials.gov ↗ ← All trials in China