Tests DZD8586 against standard treatment in adults with returned chronic lymphocytic leukemia
Tests DZD8586 against other treatments in adults with chronic lymphocytic leukemia that has returned.
Plain-language title generated from the registry record
Registry title: A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)
Key facts
- Where
- Bydgoszcz, Cracow, Gdansk, Gdynia, Katowice, Legnica, Lublin, Opole, Skorzewo, Slupsk, Walbrzych, Warsaw, and Wroclaw, PolandSee the 14 sites
- Phase
- Phase 3
Where in Poland
- In- Vivo Sp. z o. o.Bydgoszcz, PolandTaking people
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracow, PolandTaking people
- Uniwersyteckie Centrum KliniczneGdansk, PolandTaking people
- Szpitale Pomorskie Sp z o oGdynia, PolandTaking people
- Pratia Hematologia Sp. Z o. oKatowice, PolandTaking people
- Wojewodzki Szpital Specjalistyczny w LegnicyLegnica, PolandTaking people
- Uniwersytecki Szpital Kliniczny nr 4 w LublinieLublin, PolandTaking people
- Szpital Wojewodzki W Opolu Sp. z o.o.Opole, PolandTaking people
- Aidport sp z o.o.Skorzewo, PolandTaking people
- Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.Slupsk, PolandTaking people
- Specjalistyczny Szpital Im. Dra Alfreda SokolowskiegoWalbrzych, PolandTaking people
- Instytut Hematologii I TransfuzjologiiWarsaw, PolandTaking people
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyWarsaw, PolandTaking people
- Pratia S.A.Wroclaw, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Dizal Pharmaceuticals
- Trial code
- NCT07139873EU 2025-522669-32-00
- Record updated
- 3 June 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; 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; 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.