A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DZD8586, Bendamustine, Idelalisib, Rituximab.
- Who it may be relevant to
- Registry conditions: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug DZD8586
Orally, 50 mg, once daily until treatment discontinuation criterion is met. - Drug Bendamustine
Administered intravenously - Drug Idelalisib
Administered orally - Drug Rituximab
Administered intravenously
Primary outcome measures
- Progression free survival (PFS) assessed by Independent Review Committee (IRC) [Time frame: Approximately 36 Months]
Secondary outcome measures (2)
- PFS assessed by investigator [Time frame: Approximately 36 Months]
- Objective response rate (ORR) by IRC and investigator [Time frame: Approximately 36 Months]
Eligibility criteria
Inclusion criteria
- 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.
- Participants willing to comply with contraceptive restrictions.
Exclusion criteria
- 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.
- Participants with major cardiovascular disease, active infection, malignancy or uncontrolled systemic disease.
- Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
- Women who are breast feeding.
- History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital — Nanjing
- National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute o — Tianjin
Identifiers
NCT: NCT07139873 · DZ2024B0002