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
- Bangalore, Haryāna, Hyderabad, Kolkata, New Delhi, Pune, and Thiruvananthapuram, IndiaSee the 10 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic phase chronic myeloid leukemia (CML-CP) who were already treated with other TKI drugs. It tests olverembatinib, in Part A against bosutinib.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Chronic phase chronic myeloid leukemia (CML-CP). Daily functioning (ECOG performance status) of 2 or better. Adequate organ function.
- Earlier treatment
- Part A: at least two approved TKIs before. Part B: at least one approved TKI before, with no other effective or tolerable therapy available.
- Biomarker or test result
- Part B: T315I mutation at screening. Part A: T315I or V299L mutation at any time before the study treatment is not allowed.
Main reasons for not taking part
- Part A only: T315I or V299L mutation at any time before starting study treatment
- Active infection that needs drug therapy through the body (systemic)
- Stomach or bowel problem that may change how the study drugs are absorbed
- Earlier treatment with, or known or suspected allergy to, olverembatinib or bosutinib
- Pregnant or nursing women
Read by machine on 9 November 2026.
Where in India
- BangaloreBangalore, IndiaNo longer taking part
- HaryānaHaryāna, IndiaNo longer taking part
- HaryānaHaryāna, IndiaNo longer taking part
- HyderabadHyderabad, IndiaNo longer taking part
- KolkataKolkata, IndiaNo longer taking part
- KolkataKolkata, IndiaNo longer taking part
- New DelhiNew Delhi, IndiaNo longer taking part
- New DelhiNew Delhi, IndiaNo longer taking part
- PunePune, IndiaNo longer taking part
- ThiruvananthapuramThiruvananthapuram, IndiaNo longer taking part
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.