A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)
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
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
Treatments tested in this trial
- DZD8586
- Bendamustine
- Idelalisib
- Rituximab
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov