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A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)

ConditionChronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorDizal Pharmaceuticals

About this trial

This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD8586 versus investigator's choice in participants with chronic lymphocytic leukemia/small lymphocytic lymphoma who have progressed following prior therapy.

Primary objective of this study is to assess the efficacy using progression free survival assessed by independent review committee as primary endpoint. Approximately 250 participants are estimated to be randomized into the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female participants ≥ 18 years of age.

ECOG performance status 0-2.

Confirmed diagnosis of relapsed or refractory CLL/SLL with indication for treatment.

Adequate bone marrow reserve and organ system functions.

Disqualifiers

Any unresolved > Grade 1 adverse event at the time of starting study treatment.

Known or suspected Richter transformation.

Known or suspected CNS involvement.

Previous or current therapy and comedications meet exclusion criteria.

Trial design

Design model

Parallel

Treatments tested in this trial

  • DZD8586

    Drug

    Orally, 50 mg, once daily until treatment discontinuation criterion is met.

  • Bendamustine

    Drug

    Administered intravenously

  • Idelalisib

    Drug

    Administered orally

  • Rituximab

    Drug

    Administered intravenously

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Daily dose of DZD8586 (Birelentinib)Experimental treatment 1 intervention
Group B: Investigator's choiceActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Progression free survival (PFS) assessed by Independent Review Committee (IRC)

Time frame
Approximately 36 Months

Secondary outcomes

1

PFS assessed by investigator

Time frame
Approximately 36 Months
2

Objective response rate (ORR) by IRC and investigator

Time frame
Approximately 36 Months

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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