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

Dizal Pharma

Status and phase: Enrolling; Phase 3

Conditions: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Treatments: Drug: DZD8586; Drug: Idelalisib; Drug: Bendamustine; Drug: Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07139873

DZ2024B0002

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Daily dose of DZD8586 (Birelentinib)

Experimental group

Treatment:

Drug: DZD8586

Investigator's choice

Active Comparator group

Treatment:

Drug: Rituximab

Drug: Bendamustine

Drug: Idelalisib