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
- Diseases
- Chronic lymphocytic leukaemia
- 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
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCS Coordinator of this site? Confirm its status | Candiolo | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| IRCCS Azienda Ospedaliera Metropolitana Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Parma Coordinator of this site? Confirm its status | Parma | Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Azienda Unità Sanitaria Locale della Romagna Coordinator of this site? Confirm its status | Ravenna | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliera S Maria Di Terni Coordinator of this site? Confirm its status | Terni | Italy | Recruiting |
| In- Vivo Sp. z o. o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Szpitale Pomorskie Sp z o o Coordinator of this site? Confirm its status | Gdynia | Poland | Recruiting |
| Pratia Hematologia Sp. Z o. o Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Wojewodzki Szpital Specjalistyczny w Legnicy Coordinator of this site? Confirm its status | Legnica | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Szpital Wojewodzki W Opolu Sp. z o.o. Coordinator of this site? Confirm its status | Opole | Poland | Recruiting |
| Aidport sp z o.o. Coordinator of this site? Confirm its status | Skorzewo | Poland | Recruiting |
| Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o. Coordinator of this site? Confirm its status | Slupsk | Poland | Recruiting |
| Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego Coordinator of this site? Confirm its status | Walbrzych | Poland | Recruiting |
| Instytut Hematologii I Transfuzjologii Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.