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NCT07139873RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 3 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
250 (estimated)
First submitted
18 Aug 2025
Start date
8 Sept 2025
Primary completion date
31 Jan 2029
Lead sponsor
Dizal Pharmaceuticals
NCT number
NCT07139873
EU CT number
2025-522669-32-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 250
  • From 8 Sept 2025 to the primary completion date, 31 Jan 2029
  • 24 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous or current therapy and comedications meet exclusion criteria.
  • Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.

Other illness

  • Participants with major cardiovascular disease, active infection, malignancy or uncontrolled systemic disease.
  • History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.

Other

  • Any unresolved \> Grade 1 adverse event at the time of starting study treatment.
  • Known or suspected Richter transformation.
  • Known or suspected CNS involvement.
  • Women who are breast feeding.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
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NanjingChinaRecruiting
National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
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TianjinChinaRecruiting
Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCS
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CandioloItalyRecruiting
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyRecruiting
IRCCS Azienda Ospedaliera Metropolitana
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GenoaItalyRecruiting
Azienda Ospedaliero Universitaria Parma
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ParmaItalyRecruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyRecruiting
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Azienda Ospedaliera S Maria Di Terni
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TerniItalyRecruiting
In- Vivo Sp. z o. o.
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BydgoszczPolandRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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CracowPolandRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Szpitale Pomorskie Sp z o o
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GdyniaPolandRecruiting
Pratia Hematologia Sp. Z o. o
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KatowicePolandRecruiting
Wojewodzki Szpital Specjalistyczny w Legnicy
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LegnicaPolandRecruiting
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
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LublinPolandRecruiting
Szpital Wojewodzki W Opolu Sp. z o.o.
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OpolePolandRecruiting
Aidport sp z o.o.
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SkorzewoPolandRecruiting
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
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SlupskPolandRecruiting
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
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WalbrzychPolandRecruiting
Instytut Hematologii I Transfuzjologii
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WarsawPolandRecruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandRecruiting
Pratia S.A.
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WroclawPolandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.