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| Name | Class |
|---|---|
| Guangzhou Healthquest Pharma Co., Ltd | UNKNOWN |
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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).
Comparing efficacy and safety of olverembatinib in combination with chemotherapy (investigational arm) vs. investigator's choice of TKI in combination with chemotherapy (control arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olverembatinib | Experimental | Olverembatinib in combination with chemotherapy |
|
| Investigator's choice of TKI | Active Comparator | Investigator's choice of TKI in combination with chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olverembatinib | Drug | Oral (PO) once every other day (QOD). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal Residual Disease Negative CR Rate | 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. | Cycle 1 to Cycle 3 (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival (EFS) | EFS is defined as the time from study randomization to the date of treatment failure (ITF), relapse from CR, or death from any cause, whichever comes first. | Baseline up to 3 to 6 years |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ascentage Clinical Operations | Contact | 301-291-5658 | clinical-trials@ascentage.com |
| Name | Affiliation | Role |
|---|---|---|
| Elias Jabbour, M.D. | M.D. Anderson Cancer Center | Principal Investigator |
| Weili Zhao, M.D., Ph.D. | Shanghai Jiaotong University School of Medicine Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascentage Investigative Site #1044 | Not yet recruiting | Birmingham | Alabama | 35233 | United States | |
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| Investigator's choice of TKI |
| Drug |
Oral (PO) once daily (QD). |
|
According to CTCAE v5.0, the number and frequency of adverse events of test drug will be assessed. |
| Through study completion (approximately 2 years) |
| Plasma concentrations of olverembatinib | Blood samples will be collected to measure the plasma concentration of olverembatinib. | Cycle 1 to Cycle 3 (each cycle is 28 days) |
| FACT-Leu (Functional Assessment of Cancer Therapy - Leukemia) Score | To evaluate health-related Quality of Life (HR-QoL) in patients treated with olverembatinib plus chemotherapy. | Through study completion (approximately 2 years) |
| Suning Chen, M.D., Ph.D. |
| First Affiliated Hospital of Suzhou Medical College |
| Principal Investigator |
| Ascentage Investigative Site #1062 |
| Not yet recruiting |
| Duarte |
| California |
| 91010 |
| United States |
| Ascentage Investigative Site #1134 | Not yet recruiting | Los Angeles | California | 90048 | United States |
| Ascentage Investigative Site #1059 | Not yet recruiting | Los Angeles | California | 90095 | United States |
| Ascentage Investigative Site #1142 | Not yet recruiting | Miami | Florida | 33155 | United States |
| Ascentage Investigative Site #1045 | Not yet recruiting | Augusta | Georgia | 30912 | United States |
| Ascentage Investigative Site #1158 | Not yet recruiting | Indianapolis | Indiana | 46202 | United States |
| Ascentage Investigative Site #1069 | Not yet recruiting | Indianapolis | Indiana | 46237 | United States |
| Ascentage Investigative Site #1084 | Not yet recruiting | Lexington | Kentucky | 40536 | United States |
| Ascentage Investigative Site #1064 | Not yet recruiting | Hackensack | New Jersey | 07601 | United States |
| Ascentage Investigative Site #1098 | Not yet recruiting | New Brunswick | New Jersey | 08901 | United States |
| Ascentage Investigative Site #1160 | Not yet recruiting | Stony Brook | New York | 11794 | United States |
| Ascentage Investigative Site #1151 | Not yet recruiting | The Bronx | New York | 10461 | United States |
| Ascentage Investigative Site #1501 | Not yet recruiting | Houston | Texas | 77030 | United States |
| Ascentage Investigative Site #1806 | Not yet recruiting | Seattle | Washington | 98104 | United States |
| Ascentage Investigative Site #1155 | Not yet recruiting | Morgantown | West Virginia | 26506 | United States |
| Royal North Shore Hospital | Active, not recruiting | St Leonards | New South Wales | Australia |
| Royal Adelaide Hospital | Active, not recruiting | Adelaide | South Australia | 5000 | Australia |
| Alfred Health | Active, not recruiting | Melbourne | Victoria | 3004 | Australia |
| Royal Perth Hospital | Active, not recruiting | Perth | Washington | 6000 | Australia |
| The First Affiliated Hospital of Bengbu Medical School | Not yet recruiting | Bengbu | Anhui | 233000 | China |
|
| Xinqiao Hospital of Army Medical University | Recruiting | Chongqing | Chongqing Municipality | 214426 | China |
|
| Guangdong Province People's Hospital | Recruiting | Guangdong | Guangzhou | 510080 | China |
|
| Nanfang Hospital of Southern Medical University | Recruiting | Guangdong | Guangzhou | 510515 | China |
|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
|
| Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430022 | China |
|
| The First Affiliated Hospital of Suzhou University | Recruiting | Suzhou | Jiangsu | 215006 | China |
|
| Shanghai Jiao Tong University School of Medicine Ruijin Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200025 | China |
|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610044 | China |
|
| Institute of Blood Transfusion of Chinese Academy of Medical Sciences | Recruiting | Tianjin | Tianjin Municipality | 215127 | China |
|
| Ascentage Investigative Site #8647 | Not yet recruiting | Brno | 62500 | Czechia |
| Ascentage Investigative Site #6305 | Not yet recruiting | Hradec Králové | 50005 | Czechia |
| Ascentage Investigative Site #6304 | Not yet recruiting | Ostrava | 70852 | Czechia |
| Ascentage Investigative Site #6302 | Not yet recruiting | Prague | 10034 | Czechia |
| Ascentage Investigative Site #6309 | Not yet recruiting | Prague | 12800 | Czechia |
| Ascentage Investigative Site #5020 | Not yet recruiting | Le Chesnay | 78150 | France |
| Ascentage Investigative Site #5021 | Not yet recruiting | Lyon | 69008 | France |
| Ascentage Investigative Site #5013 | Not yet recruiting | Nantes | 44000 | France |
| Ascentage Investigative Site #5025 | Not yet recruiting | Nice | 06200 | France |
| Ascentage Investigative Site #5019 | Not yet recruiting | Pessac | 33604 | France |
| Ascentage Investigative Site #5024 | Not yet recruiting | Pierre-Bénite | 69495 | France |
| Ascentage Investigative Site #5022 | Not yet recruiting | Poitiers | 86021 | France |
| Ascentage Investigative Site #5018 | Not yet recruiting | Toulouse | 31059 | France |
| Ascentage Investigative Site #5538 | Not yet recruiting | Bologna | 40138 | Italy |
| Ascentage Investigative Site #5529 | Not yet recruiting | Meldola | 47014 | Italy |
| Ascentage Investigative Site #5539 | Not yet recruiting | Milan | 20132 | Italy |
| Ascentage Investigative Site #5533 | Not yet recruiting | Monza | 20900 | Italy |
| Ascentage Investigative Site #5540 | Not yet recruiting | Ravenna | 48121 | Italy |
| Ascentage Investigative Site #5531 | Not yet recruiting | Roma | 00138 | Italy |
| Ascentage Investigative Site #5550 | Not yet recruiting | Torino | 10126 | Italy |
| Ascentage Investigative Site #5536 | Not yet recruiting | Varese | 21100 | Italy |
| Ascentage Investigative Site #6503 | Not yet recruiting | Bucharest | 020125 | Romania |
| Ascentage Investigative Site #6502 | Not yet recruiting | Cluj-Napoca | 400015 | Romania |
| Ascentage Investigative Site #6507 | Not yet recruiting | Craiova | 200143 | Romania |
| Ascentage Investigative Site #6504 | Not yet recruiting | Iași | 700483 | Romania |
| Ascentage Investigative Site #6602 | Not yet recruiting | Singapore | 119074 | Singapore |
| Ascentage Investigative Site #6603 | Not yet recruiting | Singapore | 169608 | Singapore |
| Ascentage Investigative Site #6604 | Not yet recruiting | Singapore | 308433 | Singapore |
| Ascentage Investigative Site #8206 | Not yet recruiting | Busan | 49201 | South Korea |
| Ascentage Investigative Site #8207 | Not yet recruiting | Busan | 49241 | South Korea |
| Ascentage Investigative Site #8201 | Not yet recruiting | Seoul | 03080 | South Korea |
| Ascentage Investigative Site #8202 | Not yet recruiting | Seoul | 05505 | South Korea |
| Ascentage Investigative Site #8203 | Not yet recruiting | Seoul | 06591 | South Korea |
| Ascentage Investigative Site #8208 | Not yet recruiting | Uijeongbu-si | 11759 | South Korea |
| Ascentage Investigative Site #6018 | Not yet recruiting | Badalona | 08916 | Spain |
| Ascentage Investigative Site #6019 | Not yet recruiting | Badalona | 08916 | Spain |
| Ascentage Investigative Site #6020 | Not yet recruiting | Barcelona | 08035 | Spain |
| Ascentage Investigative Site #6048 | Not yet recruiting | Cáceres | 10003 | Spain |
| Ascentage Investigative Site #6016 | Not yet recruiting | Madrid | 20834 | Spain |
| Ascentage Investigative Site #6049 | Not yet recruiting | Madrid | 20840 | Spain |
| Ascentage Investigative Site #6035 | Not yet recruiting | Madrid | 28006 | Spain |
| Ascentage Investigative Site #6013 | Not yet recruiting | Madrid | 28007 | Spain |
| Ascentage Investigative Site #6011 | Not yet recruiting | Madrid | 28041 | Spain |
| Ascentage Investigative Site #6021 | Not yet recruiting | Santander | 39008 | Spain |
| Ascentage Investigative Site #6050 | Not yet recruiting | Seville | 41010 | Spain |
| Ascentage Investigative Site #6017 | Not yet recruiting | Valencia | 6017 | Spain |
| Ascentage Investigative Site #9201 | Not yet recruiting | Ankara | 06100 | Turkey (Türkiye) |
| Ascentage Investigative Site #9204 | Not yet recruiting | Ankara | 06170 | Turkey (Türkiye) |
| Ascentage Investigative Site #9212 | Not yet recruiting | Ankara | 06200 | Turkey (Türkiye) |
| Ascentage Investigative Site #9209 | Not yet recruiting | Ankara | 06560 | Turkey (Türkiye) |
| Ascentage Investigative Site #9205 | Not yet recruiting | Antalya | 07025 | Turkey (Türkiye) |
| Ascentage Investigative Site #9203 | Not yet recruiting | Istanbul | 34381 | Turkey (Türkiye) |
| Ascentage Investigative Site #9202 | Not yet recruiting | Izmir | 35100 | Turkey (Türkiye) |
| Ascentage Investigative Site #9211 | Not yet recruiting | Kayseri | 38039 | Turkey (Türkiye) |
| Ascentage Investigative Site #9208 | Not yet recruiting | Mersin | 33200 | Turkey (Türkiye) |
| Ascentage Investigative Site #9220 | Not yet recruiting | Samsun | 55139 | Turkey (Türkiye) |
| Ascentage Investigative Site #9210 | Not yet recruiting | Tekirdağ | 59030 | Turkey (Türkiye) |
| Ascentage Investigative Site #7002 | Not yet recruiting | Birmingham | B15 2GW | United Kingdom |
| Ascentage Investigative Site #7034 | Not yet recruiting | Glasgow | G12 0YN | United Kingdom |
| Ascentage Investigative Site #7019 | Not yet recruiting | London | SW3 6JJ | United Kingdom |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C579813 | olverembatinib |
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