About this trial

This is a phase 2 study to investigate the efficacy and safety of DZD8586 in combination in participants with CLL/SLL.

This study consists of two parts: Part A is the safety lead-in phase, and Part B is the dose expansion phase.

Eligibility criteria

Qualifiers

Male and female ≥ 18 years of age.

ECOG performance status 0-2, and life expectancy ≥ 6 months.

Confirmed newly diagnosis or treatment naïve CLL/SLL with indication for treatment.

Patients with SLL must have at least one measurable lesion.

Disqualifiers

Any of previous or current treatment prohibited by protocol.

Any unresolved > grade 1 drug-related adverse events.

Known or suspected Richter's transformation, or prolymphocytic leukemia.

CNS involvement.

Trial design

Treatments tested in this trial

  • DZD8586
  • Venetoclax

Treatment groups

66 Participants
are divided into 1 treatment group

Locations

15
Anhui Provincial Cancer Hospital230031, HefeiAnhui, China
Peking University Third Hospital100191, BeijingBeijing Municipality, China
Nanfang Hospital, Southern Medical University510515, GuangzhouGuangdong, China
Zhujiang Hospital of Southern Medical University510280, GuangzhouGuangdong, China

Sponsors and collaborators

Dizal Pharmaceuticals

Lead sponsor