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A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10)

ConditionChronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDizal Pharmaceuticals

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • DZD8586

    Drug

    DZD8586 will be taken orally once daily on days 1-28 of each cycle.

  • Venetoclax

    Drug

    Venetoclax will be taken orally once daily on days 1-28 starting from cycle 4 day 1.

Treatment groups

66 Participants
are divided into 1 treatment group
Group A: Combination of DZD8586 and VenetoclaxExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part A: Incidence of Adverse Events

Time frame
30 days after the last dose
2

Part B: 2-year progression free survival (PFS) rate assessed by investigator

Time frame
Approximately 5 years

Secondary outcomes

1

Part A: PFS assessed by investigator

Time frame
Approximately 5 years
2

Part A: Objective response rate (ORR) assessed by investigator

Time frame
Approximately 5 years
3

Part B: ORR assessed by investigator

Time frame
Approximately 5 years
4

Part B: Incidence of Adverse Events

Time frame
30 days after the last dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dizal Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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