A Phase 3, Open-Label, Randomized, Multicenter Study to Evaluate Anti-tumor Efficacy of DZD8586 versus Investigator's Choice in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
BirelentinibZydelig 150 mg film-coated tabletsZydelig 100 mg film-coated tabletsZydelig 150 mg film-coated tabletsTruxima 500 mg concentrate for solution for infusionZydelig 100 mg film-coated tabletsZydelig 150 mg film-coated tabletsBendamustin Hikma 25 mg/ml Pulver für ein Konzentrat zur Herstellung einer InfusionslösungZydelig 100 mg film-coated tabletsZydelig 100 mg film-coated tabletsZydelig 150 mg film-coated tabletsBendamustin Hikma 25 mg/ml Pulver für ein Konzentrat zur Herstellung einer InfusionslösungTruxima 500 mg concentrate for solution for infusionBendamustin Hikma 25 mg/ml Pulver für ein Konzentrat zur Herstellung einer InfusionslösungTruxima 500 mg concentrate for solution for infusionTruxima 500 mg concentrate for solution for infusionBendamustin Hikma 25 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Eligibility
Age group
65+ years, 18-64 years
Sex
Female, Male
Primary endpoint
• Progression free survival (PFS) assessed by Independent Review Committee (IRC) per iwCLL 2018/Lugano 2014
Endpoint detail
• PFS assessed by investigator • Objective response rate (ORR) and duration of response (DoR) assessed by IRC and investigator • Overall survival (OS) • Time to next treatment (TTNT) • EuroQol Group 5-level EQ-5D Questionnaire (EQ5D-5L) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), • Safety profiles, for example, adverse events (AEs), serious adverse events (SAEs), ≥ Grade 3 AEs, etc., per Common Terminology Criteria in Adverse Events v5.0 (CTCAE v5.0), • Plasma concentration of DZD8586 and DZ4581, and derived corresponding PK parameters
Official registry record
This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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