# Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

Source: https://onco.cc/trials/nct04662255/  
OnCo record `nct04662255` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Pirtobrutinib, Ibrutinib, Acalabrutinib and Zanubrutinib in mantle cell lymphoma, run by Loxo Oncology, Inc., active and no longer recruiting.

## Summary

Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) is a phase 3 interventional study registered as NCT04662255 by Loxo Oncology, Inc., with 500 participants enrolled, started 2021-04-08 and due to reach its primary completion in 2027-01. Interventions recorded: Pirtobrutinib, Ibrutinib, Acalabrutinib and Zanubrutinib.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT04662255
- Phase: 3
- Setting: A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)
- Sponsor: Loxo Oncology, Inc.
- Enrolled: 500

## Sources

- ClinicalTrials.gov NCT04662255: https://clinicaltrials.gov/study/NCT04662255

## Connected records

- cancers: [Mantle cell lymphoma](https://onco.cc/cancers/mantle-cell-lymphoma/)
- drugs: [Acalabrutinib](https://onco.cc/drugs/acalabrutinib/), [Ibrutinib](https://onco.cc/drugs/ibrutinib/), [Pirtobrutinib](https://onco.cc/drugs/pirtobrutinib/), [Zanubrutinib](https://onco.cc/drugs/zanubrutinib/)
- companies: [Eli Lilly (incl. Loxo)](https://onco.cc/companies/eli-lilly/)

---
JSON: https://onco.cc/api/v1/entities/nct04662255.json