Tests olverembatinib against bosutinib in chronic myeloid leukemia
Compares olverembatinib with bosutinib in adults with chronic phase chronic myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Study of Olverembatinib (HQP1351) in Patients With CML-CP
Key facts
- Where
- Cracow, Gdansk, Katowice, Legnica, Lodz, Torun, Walbrzych, and Warsaw, PolandSee the 9 sites
- Phase
- Phase 3
Where in Poland
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracow, PolandTaking people
- Copernicus Podmiot Leczniczy Sp. z o.oGdansk, PolandTaking people
- Uniwersyteckie Centrum KliniczneGdansk, PolandTaking people
- Pratia Onkologia KatowiceKatowice, PolandTaking people
- Wojewodzki Szpital Specjalistyczny w LegnicyLegnica, PolandTaking people
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w LodziLodz, PolandTaking people
- Medicover Integrated Clinical Services Sp. z o.o.Torun, PolandTaking people
- Specjalistyczny Szpital Im. Dra Alfreda SokolowskiegoWalbrzych, PolandTaking people
- Instytut Hematologii I TransfuzjologiiWarsaw, 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
- Ascentage Pharma Group Inc.
- Trial code
- NCT06423911EU 2024-511495-32-00
- Record updated
- 15 September 2026
- Original description
Study comparing efficacy and safety of olverembatinib (investigational arm) vs. bosutinib (control arm) in patients with CML-CP (Part A). Study will also evaluate efficacy and safety of olverembatinib (single-arm) in CML-CP patients with T315I mutation (Part B).Read full original descriptionShow less
A Global, Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML-CP)
Study comparing efficacy and safety of olverembatinib (investigational arm) vs. bosutinib (control arm) in patients with CML-CP (Part A). Study will also evaluate efficacy and safety of olverembatinib (single-arm) in CML-CP patients with T315I mutation (Part B).
Patients who meet ELN 2025 failure criteria while receiving bosutinib in Part A may be able to receive olverembatinib in crossover follow-on study.
Inclusion: Patients eligible for inclusion in this study must meet all of the following criteria:; Age ≥ 18 years old; Diagnosis of CML-CP; Part A: Previously treated with at least two approved TKIs; Part B: T315I mutation at screening and previously treated with at least one approved TKI, with no other effective and/or tolerable therapies available; Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2; Patient has adequate organ function.
Exclusion: For Part A only: T315I or V299L mutation at any time prior to starting study treatment; Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients; Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients; Active infection that requires systemic drug therapy; Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs; Patients eligible for this study must not meet any of the following criteria:; Pregnant or nursing (lactating) women.