UPCC 26425 A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2) (POLARIS-2)

Investigating an Investigational Medication for CP-CML

Enrolling By Invitation
18 years - 99 years
All
Phase 3
285 participants needed
1 Location

Brief description of study

A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)

Detailed description of study

The hypothesis suggests that in Part A, olverembatinib leads to a higher MMR rate compared to bosutinib in CP-CML patients without the T315I mutation; and in Part B, olverembatinib can provide therapeutic benefits to CP-CML patients with the T315I mutation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Myeloid Leukemia, CML, CML, Chronic Phase
  • Age: 18 years - 99 years
  • Gender: All

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.
  4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
  5. Written informed consent obtained prior to any screening procedures.
  6. Patients with adequate organ functions

Exclusion Criteria:

Patients eligible for this study must not meet any of the following criteria.

  1. For Part A only: T315I 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.

This study investigates the effects of an investigational medication in patients with Chronic Phase Chronic Myeloid Leukemia (CP-CML). The purpose of this study is to compare the investigational medication to another treatment in patients with CP-CML who have been previously treated with other medications.

Participants in this study will be assigned to different study arms to receive either the investigational medication or another treatment. The study will monitor the effects of these treatments on the participants' health and any side effects they may experience.

  • Who can participate: Adults aged 18 and older diagnosed with CP-CML can participate. Participants must have been treated with at least two approved TKIs or have the T315I mutation. They must have an ECOG performance status of 2 or less and adequate organ function.
  • Study details: Participants will receive treatment and be monitored for health changes and side effects. Participants must provide informed consent before joining the study.
Updated on 03 Jun 2025. Study ID: 25-1038
If you need assistance finding a non-cancer clinical research study or if you have any questions, please email psom-ocr@pobox.upenn.edu For Cancer trials contact Penn Medicine's Cancer Trial Navigator at: PMCancerResearch@pennmedicine.upenn.edu or 215-349-8245

Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

Contact Abramson Cancer Center Navigator