A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Minimal Residual Disease Negative CR Rate — Cycle 1 to Cycle 3 (each cycle is 28 days)
The minimal residual disease negative CR rate of olverembatinib combined with chemotherapy versus investigator's choice of TKI combined with chemotherapy in subjects with newly diagnosed Ph+ALL.
Trial sites (90)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 South Korea
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 South Korea