Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Summary

This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.

Timeline

Start

2021-03-09

Primary completion

2023-08-29

Completion

2027-05

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.
• Sharman JP, Munir T, Grosicki S, Roeker LE, Burke JM, Chen CI, Grzasko N, Follows G, Matrai Z, Sanna A, Qiu L, Feng R, Hua VM, Jurczak W, Ritgen M, Yi S, Bosch F, Coombs CC, Bao K, Patel V, Liu B, Compte L, Guntur A, Wang DY, Hill M, Leow CC, Ghia P, Barr PM. Phase III Trial of Pirtobrutinib Versus Idelalisib/Rituximab or Bendamustine/Rituximab in Covalent Bruton Tyrosine Kinase Inhibitor-Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321). J Clin Oncol. 2025 Aug;43(22):2538-2549. doi: 10.1200/JCO-25-00166. Epub 2025 Jun 6.

Drugs

Indications