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

Summary

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

Inclusion Criteria:

1. Male and female participants ≥ 18 years of age.
2. ECOG performance status 0-2.
3. Confirmed diagnosis of relapsed or refractory CLL/SLL with indication for treatment.
4. Adequate bone marrow reserve and organ system functions.
5. Participants willing to comply with contraceptive restrictions.

Exclusion Criteria:

1. Any unresolved \> Grade 1 adverse event at the time of starting study treatment.
2. Known or suspected Richter transformation.
3. Known or suspected CNS involvement.
4. Previous or current therapy and comedications meet exclusion criteria.
5. Participants with major cardiovascular disease, active infection, malignancy or uncontrolled systemic disease.
6. Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
7. Women who are breast feeding.
8. History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.

Conditions2

Interventions4

Related trials

• A Real-world Study of Obinutuzumab-based Therapy for Previously Untreated FL — Ruijin Hospital
• A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors — BeOne Medicines
• A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype — SecuraBio
• A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma — Guangzhou Lupeng Pharmaceutical Company LTD.
• A Study of Zanubrutinib in Combination With Polatuzumab Vedotin, Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment — Ruijin Hospital
• Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma — The Lymphoma Academic Research Organisation
• Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy — University of Birmingham

Browse More Trials