Actively Recruiting
A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)
Led by Ascentage Pharma Group Inc. · Updated on 2026-04-30
350
Participants Needed
90
Research Sites
304 weeks
Total Duration
On this page
Sponsors
A
Ascentage Pharma Group Inc.
Lead Sponsor
G
Guangzhou Healthquest Pharma Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
- Expected survival of at least 3 months
- ECOG performance status of 2 or less
- Adequate organ function
You will not qualify if you...
- History of chronic myeloid leukemia (CML)
- Presence of central nervous system (CNS) leukemia or extramedullary infiltration except lymphadenopathy or hepatosplenomegaly
- Previous or current clinical CNS diseases
- Autoimmune diseases involving the CNS
- Use of therapeutic doses of anticoagulants or antiplatelet agents (low doses allowed)
- Use of drugs with interactions with the investigational drug within 7 days or 5 half-lives prior to first dose
- Uncontrolled heart diseases
- Venous thromboembolism in the last 6 months, including deep vein thrombosis or pulmonary embolism
- Use of prohibited drugs
- Unstable disease or medical condition affecting safety or study compliance
- Use of medications known to prolong QT interval
- Active infections requiring systemic treatment
- Severe conditions affecting oral drug administration or active gastrointestinal ulcer
- Contraindications to glucocorticoids
- Bleeding disorders unrelated to ALL
- Planned major surgery
- Allergy to study drug ingredients or analogues
- Female pregnancy or breastfeeding or planning pregnancy during study
- Other malignant tumors within 2 years
- Any symptom or illness interfering with study evaluations or participation
AI-Screening
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Trial Site Locations
Total: 90 locations
1
Ascentage Investigative Site #1044
Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
Ascentage Investigative Site #1062
Duarte, California, United States, 91010
Not Yet Recruiting
3
Ascentage Investigative Site #1134
Los Angeles, California, United States, 90048
Not Yet Recruiting
4
Ascentage Investigative Site #1059
Los Angeles, California, United States, 90095
Not Yet Recruiting
5
Ascentage Investigative Site #1142
Miami, Florida, United States, 33155
Not Yet Recruiting
6
Ascentage Investigative Site #1045
Augusta, Georgia, United States, 30912
Not Yet Recruiting
7
Ascentage Investigative Site #1158
Indianapolis, Indiana, United States, 46202
Not Yet Recruiting
8
Ascentage Investigative Site #1069
Indianapolis, Indiana, United States, 46237
Not Yet Recruiting
9
Ascentage Investigative Site #1084
Lexington, Kentucky, United States, 40536
Not Yet Recruiting
10
Ascentage Investigative Site #1064
Hackensack, New Jersey, United States, 07601
Not Yet Recruiting
11
Ascentage Investigative Site #1098
New Brunswick, New Jersey, United States, 08901
Not Yet Recruiting
12
Ascentage Investigative Site #1160
Stony Brook, New York, United States, 11794
Not Yet Recruiting
13
Ascentage Investigative Site #1151
The Bronx, New York, United States, 10461
Not Yet Recruiting
14
Ascentage Investigative Site #1501
Houston, Texas, United States, 77030
Not Yet Recruiting
15
Ascentage Investigative Site #1806
Seattle, Washington, United States, 98104
Not Yet Recruiting
16
Ascentage Investigative Site #1155
Morgantown, West Virginia, United States, 26506
Not Yet Recruiting
17
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Active, Not Recruiting
18
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Active, Not Recruiting
19
Alfred Health
Melbourne, Victoria, Australia, 3004
Active, Not Recruiting
20
Royal Perth Hospital
Perth, Washington, Australia, 6000
Active, Not Recruiting
21
The First Affiliated Hospital of Bengbu Medical School
Bengbu, Anhui, China, 233000
Not Yet Recruiting
22
Xinqiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, China, 214426
Actively Recruiting
23
Guangdong Province People's Hospital
Guangdong, Guangzhou, China, 510080
Actively Recruiting
24
Nanfang Hospital of Southern Medical University
Guangdong, Guangzhou, China, 510515
Actively Recruiting
25
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
26
Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
27
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
28
Shanghai Jiao Tong University School of Medicine Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025
Not Yet Recruiting
29
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610044
Actively Recruiting
30
Institute of Blood Transfusion of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 215127
Actively Recruiting
31
Ascentage Investigative Site #8647
Brno, Czechia, 62500
Not Yet Recruiting
32
Ascentage Investigative Site #6305
Hradec Králové, Czechia, 50005
Not Yet Recruiting
33
Ascentage Investigative Site #6304
Ostrava, Czechia, 70852
Not Yet Recruiting
34
Ascentage Investigative Site #6302
Prague, Czechia, 10034
Not Yet Recruiting
35
Ascentage Investigative Site #6309
Prague, Czechia, 12800
Not Yet Recruiting
36
Ascentage Investigative Site #5020
Le Chesnay, France, 78150
Not Yet Recruiting
37
Ascentage Investigative Site #5021
Lyon, France, 69008
Not Yet Recruiting
38
Ascentage Investigative Site #5013
Nantes, France, 44000
Not Yet Recruiting
39
Ascentage Investigative Site #5025
Nice, France, 06200
Not Yet Recruiting
40
Ascentage Investigative Site #5019
Pessac, France, 33604
Not Yet Recruiting
41
Ascentage Investigative Site #5024
Pierre-Bénite, France, 69495
Not Yet Recruiting
42
Ascentage Investigative Site #5022
Poitiers, France, 86021
Not Yet Recruiting
43
Ascentage Investigative Site #5018
Toulouse, France, 31059
Not Yet Recruiting
44
Ascentage Investigative Site #5538
Bologna, Italy, 40138
Not Yet Recruiting
45
Ascentage Investigative Site #5529
Meldola, Italy, 47014
Not Yet Recruiting
46
Ascentage Investigative Site #5539
Milan, Italy, 20132
Not Yet Recruiting
47
Ascentage Investigative Site #5533
Monza, Italy, 20900
Not Yet Recruiting
48
Ascentage Investigative Site #5540
Ravenna, Italy, 48121
Not Yet Recruiting
49
Ascentage Investigative Site #5531
Roma, Italy, 00138
Not Yet Recruiting
50
Ascentage Investigative Site #5550
Torino, Italy, 10126
Not Yet Recruiting
51
Ascentage Investigative Site #5536
Varese, Italy, 21100
Not Yet Recruiting
52
Ascentage Investigative Site #6503
Bucharest, Romania, 020125
Not Yet Recruiting
53
Ascentage Investigative Site #6502
Cluj-Napoca, Romania, 400015
Not Yet Recruiting
54
Ascentage Investigative Site #6507
Craiova, Romania, 200143
Not Yet Recruiting
55
Ascentage Investigative Site #6504
Iași, Romania, 700483
Not Yet Recruiting
56
Ascentage Investigative Site #6602
Singapore, Singapore, 119074
Not Yet Recruiting
57
Ascentage Investigative Site #6603
Singapore, Singapore, 169608
Not Yet Recruiting
58
Ascentage Investigative Site #6604
Singapore, Singapore, 308433
Not Yet Recruiting
59
Ascentage Investigative Site #8206
Busan, South Korea, 49201
Not Yet Recruiting
60
Ascentage Investigative Site #8207
Busan, South Korea, 49241
Not Yet Recruiting
61
Ascentage Investigative Site #8201
Seoul, South Korea, 03080
Not Yet Recruiting
62
Ascentage Investigative Site #8202
Seoul, South Korea, 05505
Not Yet Recruiting
63
Ascentage Investigative Site #8203
Seoul, South Korea, 06591
Not Yet Recruiting
64
Ascentage Investigative Site #8208
Uijeongbu-si, South Korea, 11759
Not Yet Recruiting
65
Ascentage Investigative Site #6018
Badalona, Spain, 08916
Not Yet Recruiting
66
Ascentage Investigative Site #6019
Badalona, Spain, 08916
Not Yet Recruiting
67
Ascentage Investigative Site #6020
Barcelona, Spain, 08035
Not Yet Recruiting
68
Ascentage Investigative Site #6048
Cáceres, Spain, 10003
Not Yet Recruiting
69
Ascentage Investigative Site #6016
Madrid, Spain, 20834
Not Yet Recruiting
70
Ascentage Investigative Site #6049
Madrid, Spain, 20840
Not Yet Recruiting
71
Ascentage Investigative Site #6035
Madrid, Spain, 28006
Not Yet Recruiting
72
Ascentage Investigative Site #6013
Madrid, Spain, 28007
Not Yet Recruiting
73
Ascentage Investigative Site #6011
Madrid, Spain, 28041
Not Yet Recruiting
74
Ascentage Investigative Site #6021
Santander, Spain, 39008
Not Yet Recruiting
75
Ascentage Investigative Site #6050
Seville, Spain, 41010
Not Yet Recruiting
76
Ascentage Investigative Site #6017
Valencia, Spain, 6017
Not Yet Recruiting
77
Ascentage Investigative Site #9201
Ankara, Turkey (Türkiye), 06100
Not Yet Recruiting
78
Ascentage Investigative Site #9204
Ankara, Turkey (Türkiye), 06170
Not Yet Recruiting
79
Ascentage Investigative Site #9212
Ankara, Turkey (Türkiye), 06200
Not Yet Recruiting
80
Ascentage Investigative Site #9209
Ankara, Turkey (Türkiye), 06560
Not Yet Recruiting
81
Ascentage Investigative Site #9205
Antalya, Turkey (Türkiye), 07025
Not Yet Recruiting
82
Ascentage Investigative Site #9203
Istanbul, Turkey (Türkiye), 34381
Not Yet Recruiting
83
Ascentage Investigative Site #9202
Izmir, Turkey (Türkiye), 35100
Not Yet Recruiting
84
Ascentage Investigative Site #9211
Kayseri, Turkey (Türkiye), 38039
Not Yet Recruiting
85
Ascentage Investigative Site #9208
Mersin, Turkey (Türkiye), 33200
Not Yet Recruiting
86
Ascentage Investigative Site #9220
Samsun, Turkey (Türkiye), 55139
Not Yet Recruiting
87
Ascentage Investigative Site #9210
Tekirdağ, Turkey (Türkiye), 59030
Not Yet Recruiting
88
Ascentage Investigative Site #7002
Birmingham, United Kingdom, B15 2GW
Not Yet Recruiting
89
Ascentage Investigative Site #7034
Glasgow, United Kingdom, G12 0YN
Not Yet Recruiting
90
Ascentage Investigative Site #7019
London, United Kingdom, SW3 6JJ
Not Yet Recruiting
Research Team
A
Ascentage Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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