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
- Albuquerque, Amarillo, Anchorage, Augusta, Austin, Baltimore, Birmingham, Chattanooga, Chicago, Cleveland, Decatur, Detroit, Duarte, Edmonds, Goodyear, Greenville, Hackensack, Houston, Indianapolis, Irvine, Issaquah, La Jolla, Las Vegas, Lexington, Lincoln, Long Beach, Los Angeles, Louisville, Mayfield Heights, Morristown, Morrisville, Nashville, New Brunswick, Newnan, Philadelphia, Pittsburgh, Portland, Reno, Rochester, Sacramento, Seattle, Shirley, St Louis, Stony Brook, Upland, Virginia Beach, and Wichita, United StatesSee the 50 sites
- Phase
- Phase 3
Where in United States
- AlbuquerqueAlbuquerque, United StatesTaking people
- AmarilloAmarillo, United StatesTaking people
- AnchorageAnchorage, United StatesTaking people
- AugustaAugusta, United StatesTaking people
- AustinAustin, United StatesTaking people
- BaltimoreBaltimore, United StatesTaking people
- BirminghamBirmingham, United StatesTaking people
- ChattanoogaChattanooga, United StatesTaking people
- ChicagoChicago, United StatesTaking people
- ClevelandCleveland, United StatesNot yet recruiting
- ClevelandCleveland, United StatesNot yet recruiting
- DecaturDecatur, United StatesTaking people
- DetroitDetroit, United StatesTaking people
- DetroitDetroit, United StatesTaking people
- DuarteDuarte, United StatesTaking people
- EdmondsEdmonds, United StatesTaking people
- GoodyearGoodyear, United StatesTaking people
- GreenvilleGreenville, United StatesNot yet recruiting
- HackensackHackensack, United StatesTaking people
- HoustonHouston, United StatesTaking people
- IndianapolisIndianapolis, United StatesTaking people
- IrvineIrvine, United StatesTaking people
- IssaquahIssaquah, United StatesTaking people
- La JollaLa Jolla, United StatesTaking people
- Las VegasLas Vegas, United StatesTaking people
- LexingtonLexington, United StatesTaking people
- LincolnLincoln, United StatesNot yet recruiting
- Long BeachLong Beach, United StatesTaking people
- Los AngelesLos Angeles, United StatesTaking people
- LouisvilleLouisville, United StatesTaking people
- Mayfield HeightsMayfield Heights, United StatesNot yet recruiting
- MorristownMorristown, United StatesTaking people
- MorrisvilleMorrisville, United StatesTaking people
- NashvilleNashville, United StatesTaking people
- New BrunswickNew Brunswick, United StatesTaking people
- NewnanNewnan, United StatesTaking people
- PhiladelphiaPhiladelphia, United StatesTaking people
- PittsburghPittsburgh, United StatesTaking people
- PortlandPortland, United StatesNot yet recruiting
- RenoReno, United StatesTaking people
- RochesterRochester, United StatesTaking people
- SacramentoSacramento, United StatesTaking people
- SeattleSeattle, United StatesTaking people
- SeattleSeattle, United StatesTaking people
- ShirleyShirley, United StatesTaking people
- St LouisSt Louis, United StatesTaking people
- Stony BrookStony Brook, United StatesNot yet recruiting
- UplandUpland, United StatesTaking people
- Virginia BeachVirginia Beach, United StatesTaking people
- WichitaWichita, United StatesTaking 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.