drugset / Trial / NCT04662255
Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.
Timeline
- Start
- 2021-04-08
- Primary completion
- 2027-01
- Completion
- 2028-04
Publications
- 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. doi: 10.1186/s41687-026-01126-w. Online ahead of print.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acalabrutinib | Small molecule | — | — |
| Comparator | Ibrutinib | Small molecule | — | — |
| Subject | Pirtobrutinib | Other / unclassified | — | — |
| Comparator | Zanubrutinib | Small molecule | — | — |