CELESTIAL-TN CLL | BGB-11417-301

Sonrotoclax, ZanubrutinibCLLPhase 3Active, not recruiting

Summary

The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)

Detailed Description

In this study, participants with CLL without prior treatment will receive either venetoclax plus obinutuzumab combination treatment that is considered a standard first line treatment or receive sonrotoclax plus zanubrutinib. It is hypothesized that sonrotoclax plus zanubrutinib may be better than venetoclax plus obinutuzumab in treating CLL.

 

The main purpose of this study is to compare the duration the participants live without the CLL getting worse between participants who received sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab. Approximately 652 participants will be included in this study around the world. Participants will have equal chance to be allocated to receive either of the treatment combinations.

Study ArmPopulationInterventionComparisonOutcome

TN CLL


Zanubrutinib + Sonrotoclax


Venetoclax + Obinutuzumab


Primary Endpoint: PFS (IRC)


Key Secondary Endpoints: CR rate (IRC, INV), uMRD4 rate, OS, PFS (INV), ORR (IRC, INV), DoR (IRC, INV), PROs, safety and tolerability


Study design

A study design schema for the CELESTIAL-TN CLL Trial. It lists key eligibility criteria, stratification factors, and treatment arms: sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab.

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