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

Source: https://onco.cc/trials/nct07377578/  
OnCo record `nct07377578` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing Rocbrutinib in mantle cell lymphoma, now recruiting.

## Summary

A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma is a phase 3 interventional study registered as NCT07377578, led by Guangzhou Lupeng Pharmaceutical, and recruiting on the registry. Official title: A Randomised, Open-label, Multicenter, Phase III Clinical Study Comparing Rocbrutinib Monotherapy Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL) (PRIME Study). Planned enrolment is 394 participants (estimated). The study started in 2026-02-05 and primary completion is expected in 2031-05-30. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Tags: ctgov-ingest
- Registry id: NCT07377578
- Phase: 3
- Setting: A Randomized, Open-label, Multicenter, Phase III Clinical Study Comparing Rocbrutinib Monotherapy Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL) (PRIME Study)
- Sponsor: Guangzhou Lupeng Pharmaceutical
- Enrolled: 394

## Sources

- ClinicalTrials.gov NCT07377578: https://clinicaltrials.gov/study/NCT07377578

## Connected records

- cancers: [Mantle cell lymphoma](https://onco.cc/cancers/mantle-cell-lymphoma/)
- drugs: [Rocbrutinib](https://onco.cc/drugs/rocbrutinib/)
- companies: [Lupeng Pharmaceuticals](https://onco.cc/companies/lupeng-pharmaceuticals/)

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