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Taking people in SingaporePhase 3

Tests olverembatinib against bosutinib in chronic myeloid leukemia

Compares olverembatinib with bosutinib in adults with chronic phase chronic myeloid leukemia.

Key facts

Who runs it
Ascentage Pharma Group Inc.
Where
Singapore, SingaporeSee the 2 sitesAlso in 15 other countries, 164 sites
Registry title
Study of Olverembatinib (HQP1351) in Patients With CML-CP
Status
Recruiting
Phase
Phase 3
People taking part
333 people, planned
Started
5 Feb 2024
Expected to end
10 Jul 2028
Type of study
Interventional, 2 groups
Treatments tested
  • olverembatinib
  • Bosutinib
Record updated
15 September 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Singapore

Also in 15 other countries, 164 sites

  • SingaporeHospital not named in the registryContact: Ascentage Clinical OperationsTaking people
  • SingaporeHospital not named in the registryContact: Ascentage Clinical OperationsTaking people

About the trial

What the trial wants to find out

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

Patients who meet ELN 2025 failure criteria while receiving bosutinib in Part A may be able to receive olverembatinib in crossover follow-on study.

The 2 groups in the trial

  • Part A, RCT, olverembatinib arm and bosutinib armOther group

    Randomized controlled part that is designed to compare the efficacy and safety of olverembatinib (investigational arm) versus bosutinib (control arm) in patients with CML-CP, previously treated with at least two TKIs

    Treatment: olverembatinib and Bosutinib

  • Part B, SAT, olverembatinib armOther group

    To evaluate the efficacy and safety of olverembatinib in the CML-CP patients with T315I mutation previously

    Treatment: olverembatinib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Global, Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML-CP)
Plain-language title
Tests olverembatinib against bosutinib in chronic myeloid leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
15 September 2026