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Zanubrutinib vs Ibrutinib in R/R CLL/SLL
NCT03734016Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2018
- Primary completion
- Aug 2022
- Countries
- 15
- Sponsor
- BeiGene
- Modality
- Fragment-Derived Small Molecules, Reversible Covalent Inhibitors, Bivalent/Multivalent Binders
- Drugs
- zanubrutinib
- Conditions
- chronic lymphocytic leukemia (CLL)small lymphocytic lymphoma (SLL)
01
Overview
Phase 3, randomised, open-label trial of zanubrutinib in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) (2 arms), sponsored by BeiGene. Primary endpoints: Overall Response Rate Assessed by the Investigator at 29.6 months and Overall Response Rate Assessed by Independent Review Committee at 29.6 months. Started Nov 2018; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Zanubrutinib
Zanubrutinib 160 mg BID
Ibrutinib
Ibrutinib 420 mg QD
03
Who it enrols
Adult patients with confirmed R/R CLL/SLL requiring treatment who have received at least 1 prior systemic therapy, have measurable disease, and ECOG PS 0-2. Patients with Richter's transformation, prior BTK inhibitor treatment, or significant cardiovascular disease are excluded.
04
Endpoints
Primary
Overall Response Rate Assessed by the Investigator
Overall Response Rate Assessed by Independent Review Committee
Secondary
Progression-free Survival Assessed by the Investigator
Progression-free Survival Assessed by the Independent Review Committee
Percentage of Participants With Atrial Fibrillation or Atrial Flutter
Duration of Response Assessed by the Independent Review Committee
Duration of Response Assessed by the Investigator
Time to Treatment Failure
Rate of Partial Response With Lymphocytosis or Higher Assessed by IRC
Rate of Partial Response With Lymphocytosis or Higher Assessed by Investigator
05
Results
Primary endpoints met
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