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
- Bologna, Candiolo, Catania, Lecce, Meldola, Messina, Milan, Naples, Novara, Padova, Pisa, Rome, Turin, and Varese, ItalySee the 17 sites
- Phase
- Phase 3
Where in Italy
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
- INOC Istituto Nazionale Oncologico CandioloCandiolo, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, ItalyTaking people
- Ospedale Vito Fazzi LecceLecce, ItalyTaking people
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
- Azienda Ospedaliera Universitaria Gaetano Martino MessinaMessina, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyTaking people
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, ItalyTaking people
- Azienda Ospedaliera di PadovaPadova, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Azienda Sanitaria Locale Roma 2Rome, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, ItalyTaking people
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Dei Sette LaghiVarese, ItalyTaking 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.