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

Recruiting now · Phase 3

Conditions studied: Ph+ ALL, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

In brief

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).

Key facts

Study ID

NCT06051409

Run by

Ascentage Pharma Group Inc.

People needed

350

Starts

2023-08-31

Expected to finish

2029-06-30

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
• Expected survival of at least 3 months
• ECOG ≤ 2
• Adequate organ function

You may not qualify if…

• A history of chronic myeloid leukemia (CML)
• Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly
• Previous or current clinical CNS diseases
• Autoimmune diseases that may involve the CNS
• Use of therapeutic doses of anticoagulants and/or antiplatelet agents; low doses of anticoagulants or antiplatelet agents are allowed
• 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
• Uncontrolled heart diseases
• Any venous thromboembolism in the 6 months prior to randomization, including but not limited to deep vein thrombosis (DVT) or pulmonary embolism
• Use of prohibited drugs
• Disease or medical condition that is unstable or may affect its safety or compliance with the study
• Use of medications known to cause prolonged QT interval
• Active infections requiring systemic treatment
• Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer
• Contraindications to the use of glucocorticoids
• Bleeding disorders unrelated to ALL
• Plan to undergo major surgery
• Allergy to drug ingredients, excipients, or their analogues in the study
• Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study period
• Other malignant tumors within 2 years
• 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

Where it is running

• The First Affiliated Hospital of Suzhou University — Suzhou, Jiangsu, China (enrolling)
• Xinqiao Hospital of Army Medical University — Chongqing, Chongqing Municipality, China (enrolling)
• Guangdong Province People's Hospital — Guangdong, Guangzhou, China (enrolling)
• Institute of Blood Transfusion of Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (enrolling)
• Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (enrolling)
• Nanfang Hospital of Southern Medical University — Guangdong, Guangzhou, China (enrolling)
• Ascentage Investigative Site #1158 — Indianapolis, Indiana, United States
• Ascentage Investigative Site #1160 — Stony Brook, New York, United States
• Ascentage Investigative Site #1045 — Augusta, Georgia, United States
• Ascentage Investigative Site #1151 — The Bronx, New York, United States
• Ascentage Investigative Site #1501 — Houston, Texas, United States
• Ascentage Investigative Site #1806 — Seattle, Washington, United States
• Ascentage Investigative Site #1134 — Los Angeles, California, United States
• Ascentage Investigative Site #1098 — New Brunswick, New Jersey, United States
• Royal Perth Hospital — Perth, Washington, Australia
• Ascentage Investigative Site #1064 — Hackensack, New Jersey, United States
• Ascentage Investigative Site #1142 — Miami, Florida, United States
• The First Affiliated Hospital of Bengbu Medical School — Bengbu, Anhui, China
• Alfred Health — Melbourne, Victoria, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Ascentage Investigative Site #1084 — Lexington, Kentucky, United States
• Royal North Shore Hospital — St Leonards, New South Wales, Australia
• Ascentage Investigative Site #1155 — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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