RightFit
RecruitingPhase 3

Study of Olverembatinib (HQP1351) in Patients With CML-CP

A Global, Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML-CP)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well olverembatinib works and how safe it is for adults with chronic-phase chronic myeloid leukemia (CML-CP), a blood cancer. Part A compares it with bosutinib in people who have tried at least two targeted cancer drugs. Part B tests olverembatinib alone in people with a gene change called T315I who have tried at least one targeted drug and have no other treatment that works or is tolerable.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You have CML-CP, the chronic phase of chronic myeloid leukemia.
  • For Part A: You have been treated with at least two approved TKIs, a type of targeted cancer drug.
  • For Part B: Tests show the T315I gene change. You have tried at least one approved TKI and have no other treatment that works or has side effects you can handle.
  • You can care for yourself and are out of bed or a chair for more than half of your waking hours, even if you cannot work (ECOG score 0–2).
  • Your organs work well enough for the study.

Who can't join

  • For Part A only: You have had the T315I or V299L gene change at any time before study treatment.
  • You have an active infection that needs medicine that acts throughout the body.
  • You have a stomach or bowel problem that could greatly affect how your body absorbs the study drugs.
  • You have taken olverembatinib before, or you have a known or suspected allergy to it or any of its ingredients.
  • You have taken bosutinib before, or you have a known or suspected allergy to it or any of its ingredients.
  • You are pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria Patients eligible for inclusion in this study must meet all of the following criteria: 1. Age ≥ 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) ≤ 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

Study sites (50)

AK

AL

AZ

CA

GA

IL

IN

KS

KY

MD

MI

MO

NC

NE

NJ

NM

NV

NY

OH

OR

PA

TN

TX

VA

WA