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Clinical trial · no report yet · Phase 3
BRUIN-MCL-321
Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)
- NCT04662255 ↗
- Active, not recruiting
- Loxo Oncology, Inc.
- Standard
We haven't built an HCP commentary report on BRUIN-MCL-321 (pirtobrutinib in previously treated BTK inhibitor naïve mantle cell lymphoma) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on BRUIN-MCL-321 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| YouTube | 6 | |
| Podcasts | 3 | |
| X threads | 2 |
The trial
ClinicalTrials.gov- Official title
- 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)
- Phase
- Phase 3
- Status
- Active, not recruiting
- Conditions
- Lymphoma, Mantle-Cell
- Interventions
- Pirtobrutinib; Ibrutinib; Acalabrutinib; Zanubrutinib
- Arms
- Arm A (Pirtobrutinib) · Experimental
- Arm B (Ibrutinib, Acalabrutinib, or Zanubrutinib) · Active comparator
- Enrollment
- 500 (estimated)
- Primary outcomes
- To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL)
- Sponsor
- Loxo Oncology, Inc. with Eli Lilly and Company
- Start
- Apr 8, 2021
- Primary completion
- Nov 2027 (estimated)
- Results posted
- No
- Registry record
- NCT04662255 · updated Sep 23, 2026
Publications
linked from the registry- Loubert A, Creel K, Bhandari NR, Hess LM, Ruppert AS, Abada P, Regnault A, Payakachat N. Psychometric analysis of new lymphoma-specific patient-reported symptom measures derived from the EORTC item library. J Patient Rep Outcomes. 2026 Jun 22;10(1):109. doi: 10.1186/s41687-026-01126-w. PubMed 42329537
- Eyre TA, Shah NN, Dreyling M, Jurczak W, Wang Y, Cheah CY, Song Y, Gandhi M, Chay C, Sharman J, Andorsky DJ, Messersmith HM, Ruppert AS, Muthig VA, Ito R, Wang ML. BRUIN MCL-321: phase III study of pirtobrutinib versus investigator choice of BTK inhibitor in BTK inhibitor naive mantle cell lymphoma. Future Oncol. 2022 Nov;18(36):3961-3969. doi: 10.2217/fon-2022-0976. Epub 2022 Nov 15. PubMed 36377973