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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522669-32-00

Acronym

DZ2024B0002

Enrollment

Registered

2025-11-03

Start date

2025-12-18

Completion date

Unknown

Last updated

2025-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Brief summary

• Progression free survival (PFS) assessed by Independent Review Committee (IRC) per iwCLL 2018/Lugano 2014

Detailed description

• 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

Interventions

DRUGZydelig 100 mg film-coated tablets

DRUGBendamustin Hikma 2

DRUG5 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

DRUGZydelig 150 mg film-coated tablets

DRUGTruxima 500 mg concentrate for solution for infusion

DRUGBirelentinib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Progression free survival (PFS) assessed by Independent Review Committee (IRC) per iwCLL 2018/Lugano 2014	—

Secondary

Measure	Time frame
• 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	—

Measure

Time frame

—

Countries

Italy, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026