RECRUITING

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

Conditions

Chronic Myeloid Leukemia CML CML, Chronic Phase

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

This is a Global, Multi-center, Open-label Randomized and Registrational Phase 3 Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia

Quick Facts

Study Start:2024-02-05

Study Completion:2026-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06423911

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

Ben Little

CONTACT

301-509-3222

ben.little@ascentage.com

Huanshan Guo

CONTACT

huanshan.guo@ascentage.com

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Ascentage Pharma Group Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-05

Study Completion Date2026-02

Study Record Updates

Study Start Date2024-02-05

Study Completion Date2026-02

Terms related to this study

Additional Relevant MeSH Terms

Chronic Myeloid Leukemia
CML
CML, Chronic Phase