Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With CLL or SLL

Titre officiel

A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)

Sommaire:

Il s’agit d’une étude visant les patients atteints de leucémie lymphoïde chronique (LLC) ou de lymphome à petits lymphocytes (LPL) qui ont déjà reçu un traitement avec au moins un inhibiteur de la tyrosine kinase de Bruton (BTK). L’objectif principal est de comparer le LOXO-305 à l’idélalisib plus rituximab ou à la bendamustine plus rituximab. La participation pourrait durer jusqu’à quatre ans, voire plus longtemps, si la maladie ne progresse pas.

Description de l'essai

Primary Outcome:

• To evaluate progression-free survival (PFS) of LOXO-305 monotherapy (Arm A) compared to investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) (Arm B)

Secondary Outcome:

• To evaluate the effectiveness of Arm A compared to Arm B based on Overall Response Rate (ORR)
• To evaluate the effectiveness of Arm A compared to Arm B based on Overall Survival (OS)
• To evaluate the effectiveness of Arm A compared to Arm B based on Time to Next Treatment (TTNT)
• Time to worsening (TTW) of CLL/SLL related symptoms
• Time to worsening (TTW) of physical function

This is a Phase 3 global, randomized, open-label study comparing LOXO-305 (Arm A) to investigator's choice of either idelalisib plus rituximab or bendamustine plus rituximab (Arm B) in CLL/SLL patients who have been treated with at least a covalent BTK inhibitor (BTKi). Patients may have discontinued the prior covalent BTKi due to disease progression (PD) or intolerance. Patients who have received venetoclax are eligible for the study. Eligible patients will be randomized in 1:1 to Arm A and Arm B.

Voir cet essai sur ClinicalTrials.gov