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โ† Trials
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Study of Olverembatinib (HQP1351) in Patients With CML-CP

RecruitingPhase 3Ages 18 Years - anyAllAscentage Pharma Group Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria Patients eligible for inclusion in this study must meet all of the following criteria: 1. Age โ‰ฅ 18 years old 2. Diagnosis of CML-CP 3. 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 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) โ‰ค 2 5. Patient has adequate organ function Exclusion Criteria Patients eligible for this study must not meet any of the following criteria: 1. For Part A only: T315I or V299L mutation at any time prior to starting study treatment 2. Active infection that requires systemic drug therapy 3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs 4. Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients 5. Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients 6. Pregnant or nursing (lactating) women
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What it tests

  • olverembatinib
  • Bosutinib
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Where

163 sites
Ascentage Investigative Site #1044
Birmingham, United States
Ascentage Investigative Site #1112
Anchorage, United States
Ascentage Investigative Site #1111
Goodyear, United States
Ascentage Investigative Site #1062
Duarte, United States
Ascentage Investigative Site #1099
Irvine, United States
Ascentage Investigative Site #1075
La Jolla, United States
Ascentage Investigative Site #1100
Long Beach, United States
Ascentage Investigative Site #1059
Los Angeles, United States

โ€ฆand 155 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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