Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaPhase 3NCT07139873
A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)
A Phase 3 study testing DZD8586, Bendamustine and Idelalisib in people with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Dizal Pharmaceuticals at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- What is being tested?
- DZD8586, Bendamustine and Idelalisib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesChina
- Study dates
- 8 Sep 2025to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjing, Jiangsu
- Recruiting
National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality
About this study
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
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.
- Being tested
- DZD8586, Bendamustine, Idelalisib, Rituximab
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DZD8586Drug
Also called Birelentinib
Orally, 50 mg, once daily until treatment discontinuation criterion is met.
BendamustineDrug
Administered intravenously
IdelalisibDrug
Administered orally
RituximabDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Daily dose of DZD8586 (Birelentinib) | Experimental | Not described Receives: Drug: DZD8586 |
| Investigator's choice | Active comparator | Not described Receives: Drug: Bendamustine; Drug: Idelalisib; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) assessed by Independent Review Committee (IRC)
Measured: Approximately 36 Months
Secondary outcomes (2)
PFS assessed by investigator
Measured: Approximately 36 Months
Objective response rate (ORR) by IRC and investigator
Measured: Approximately 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start8 Sep 2025
- Primary completionJan 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaStudies of the same condition, open and under way.
- More trials run by Dizal PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dizal Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Dizal Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139873
- Sponsor's protocol ID
- DZ2024B0002
- Status last verified
- Jun 2026
- First submitted
- 18 Aug 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07139873
- Acronym / sponsor ID
- DZ2024B0002
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Dizal PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily dose of DZD8586 (Birelentinib) | Experimental | Drug: DZD8586 |
| Investigator's choice | Active comparator | Drug: Bendamustine, Drug: Idelalisib, Drug: Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DZD8586Also: BirelentinibOrally, 50 mg, once daily until treatment discontinuation criterion is met. | Drug | Daily dose of DZD8586 (Birelentinib) |
| BendamustineAdministered intravenously | Drug | Investigator's choice |
| IdelalisibAdministered orally | Drug | Investigator's choice |
| RituximabAdministered intravenously | Drug | Investigator's choice |
Primary outcome
Progression free survival (PFS) assessed by Independent Review Committee (IRC)
Time frame: Approximately 36 Months
2 secondary outcomes
PFS assessed by investigator
Time frame: Approximately 36 Months
Objective response rate (ORR) by IRC and investigator
Time frame: Approximately 36 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Dizal Pharmaceutical Co., Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DZD8586, Bendamustine and Idelalisib in people with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Dizal Pharmaceuticals at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cong Wei (0086-21-61097873, Cong.Wei@dizalpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) assessed by Independent Review Committee (IRC) (time frame: Approximately 36 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.