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Clinical Trials in the UK / NCT06051409
Recruiting Phase 3

A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)

NCT06051409 · tracked via the Priya Life Science UK tracker
Sponsor
Ascentage Pharma Group Inc.
Phase
Phase 3
Started
2023-08-31
Last updated
2026-04-30

Condition(s) studied

Ph+ ALLLeukemia, Lymphoblastic, Acute, Philadelphia-Positive

Investigational drug(s) / intervention(s)

OlverembatinibInvestigator's choice of TKI

Olverembatinib: Oral (PO) once every other day (QOD).

Investigator's choice of TKI: Oral (PO) once daily (QD).

Study summary

A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of olverembatinib combined with chemotherapy versus investigator's choice of tyrosine kinase inhibitor (TKI) combined with chemotherapy in subjects with newly-diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL) 2. Expected survival of at least 3 months 3. ECOG ≤ 2 4. Adequate organ function Exclusion Criteria: 1. A history of chronic myeloid leukemia (CML) 2. Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly 3. Previous or current clinical CNS diseases 4. Autoimmune diseases that may involve the CNS 5. Use of therapeutic doses of anticoagulants and/or antiplatelet agents; low doses of anticoagulants or antiplatelet agents are allowed 6. Use a therapeutic drug that has drug interaction with the investigational drug due to other diseases within 7 days or within 5 half-lives (whichever is shorter) prior to the first receipt of the investigational drug 7. Uncontrolled heart diseases 8. Any venous thromboembolism in the 6 months prior to randomization, including but not limited to deep vein thrombosis (DVT) or pulmonary embolism 9. Use of prohibited drugs 10. Disease or medical condition that is unstable or may affect its safety or compliance with the study 11. Use of medications known to cause prolonged QT interval 12. Active infections requiring systemic treatment 13. Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer 14. Contraindications to the use of glucocorticoids 15. Bleeding disorders unrelated to ALL 16. Plan to undergo major surgery 17. Allergy to drug ingredients, excipients, or their analogues in the study 18. Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study period 19. Other malignant tumors within 2 years 20. Any symptom or illness that may interfere with the evaluation of the efficacy and safety of the investigational drug, or any other condition or condition that is not appropriate for participation in the study

Primary outcome measure(s)

Trial sites (90)

FacilityCityRegionStatus
Ascentage Investigative Site #1044 Birmingham Alabama Not Yet Recruiting
Ascentage Investigative Site #1062 Duarte California Not Yet Recruiting
Ascentage Investigative Site #1134 Los Angeles California Not Yet Recruiting
Ascentage Investigative Site #1059 Los Angeles California Not Yet Recruiting
Ascentage Investigative Site #1142 Miami Florida Not Yet Recruiting
Ascentage Investigative Site #1045 Augusta Georgia Not Yet Recruiting
Ascentage Investigative Site #1158 Indianapolis Indiana Not Yet Recruiting
Ascentage Investigative Site #1069 Indianapolis Indiana Not Yet Recruiting
Ascentage Investigative Site #1084 Lexington Kentucky Not Yet Recruiting
Ascentage Investigative Site #1064 Hackensack New Jersey Not Yet Recruiting
Ascentage Investigative Site #1098 New Brunswick New Jersey Not Yet Recruiting
Ascentage Investigative Site #1160 Stony Brook New York Not Yet Recruiting
Ascentage Investigative Site #1151 The Bronx New York Not Yet Recruiting
Ascentage Investigative Site #1501 Houston Texas Not Yet Recruiting
Ascentage Investigative Site #1806 Seattle Washington Not Yet Recruiting
Ascentage Investigative Site #1155 Morgantown West Virginia Not Yet Recruiting
Royal North Shore Hospital St Leonards New South Wales Active Not Recruiting
Royal Adelaide Hospital Adelaide South Australia Active Not Recruiting
Alfred Health Melbourne Victoria Active Not Recruiting
Royal Perth Hospital Perth Washington Active Not Recruiting
The First Affiliated Hospital of Bengbu Medical School Bengbu Anhui Not Yet Recruiting
Xinqiao Hospital of Army Medical University Chongqing Chongqing Municipality Recruiting
Guangdong Province People's Hospital Guangdong Guangzhou Recruiting
Nanfang Hospital of Southern Medical University Guangdong Guangzhou Recruiting
Henan Cancer Hospital Zhengzhou Henan Recruiting
Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei Recruiting
The First Affiliated Hospital of Suzhou University Suzhou Jiangsu Recruiting
Shanghai Jiao Tong University School of Medicine Ruijin Hospital Shanghai Shanghai Municipality Not Yet Recruiting
West China Hospital of Sichuan University Chengdu Sichuan Recruiting
Institute of Blood Transfusion of Chinese Academy of Medical Sciences Tianjin Tianjin Municipality Recruiting
Ascentage Investigative Site #8647 Brno Czechia Not Yet Recruiting
Ascentage Investigative Site #6305 Hradec Králové Czechia Not Yet Recruiting
Ascentage Investigative Site #6304 Ostrava Czechia Not Yet Recruiting
Ascentage Investigative Site #6302 Prague Czechia Not Yet Recruiting
Ascentage Investigative Site #6309 Prague Czechia Not Yet Recruiting
Ascentage Investigative Site #5020 Le Chesnay France Not Yet Recruiting
Ascentage Investigative Site #5021 Lyon France Not Yet Recruiting
Ascentage Investigative Site #5013 Nantes France Not Yet Recruiting
Ascentage Investigative Site #5025 Nice France Not Yet Recruiting
Ascentage Investigative Site #5019 Pessac France Not Yet Recruiting

+ 50 more sites — see the full list on the official registry below.

More Ascentage Pharma Group Inc. trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06051409 on ClinicalTrials.gov ↗ ← All trials in the UK