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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences | OTHER |
| Handan Central Hospital | OTHER |
| Taian City Central Hospital | OTHER |
| Tianjin People's Hospital |
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This study proposes to conduct a prospective, multicenter, single-arm study to explore the efficacy and safety of venetoclax in combination with high-dose decitabine (DEC3-VEN) in new diagnosed adult patients with AML, and to provide evidence for the optimal selection of clinical treatment regimens, which is planned to be conducted in 10 research centers across the country.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax in combination with Decitabine (+-sorafenib) | Experimental | Venetoclax in combination with decitabine (+-sorafenib) Venetoclax (VEN) 100mg d1, 200mg d2, 400mg d3-14 Decitabine (DEC) 20mg/m2/q8h, d4-6 (infusion time >2h) Sorafenib 800mg/d, d8-14 (only for FLT3/ITD mutation positive patients) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEC3-VEN | Procedure | Venetoclax in combination with decitabine (+-sorafenib) Venetoclax (VEN) 100mg d1, 200mg d2, 400mg d3-14 Decitabine (DEC) 20mg/m2/q8h, d4-6 (infusion time >2h) Sorafenib 800mg/d, d8-14 (only for FLT3/ITD mutation positive patients) |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | ORR (include CR, CRi, MLFS, PR) of the first course of Venetoclax in combination with high-dose decitabine for the treatment of newly-diagnosed AML adult patients. | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | defined as the time period from initiation of study medication to death from any cause. | up to 24 months |
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Inclusion Criteria:
Subjects suitable for enrollment in this study must meet all of the following criteria:
Exclusion Criteria:
Subjects may not be enrolled in this study if they meet any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZePing Zhou | Contact | 18788571605 | zhouzeping@kmmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Kunming Medical University. | Kunming | Yunnan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12424199 | Background | Del Poeta G, Venditti A, Del Principe MI, Maurillo L, Buccisano F, Tamburini A, Cox MC, Franchi A, Bruno A, Mazzone C, Panetta P, Suppo G, Masi M, Amadori S. Amount of spontaneous apoptosis detected by Bax/Bcl-2 ratio predicts outcome in acute myeloid leukemia (AML). Blood. 2003 Mar 15;101(6):2125-31. doi: 10.1182/blood-2002-06-1714. Epub 2002 Nov 7. | |
| 30499168 |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| OTHER |
| Guizhou Provincial People's Hospital | OTHER |
| Central South University | OTHER |
| Western Theater General Hospital | UNKNOWN |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Chengdu Jingdongfang Hospital | UNKNOWN |
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| Mei M, Aldoss I, Marcucci G, Pullarkat V. Hypomethylating agents in combination with venetoclax for acute myeloid leukemia: Update on clinical trial data and practical considerations for use. Am J Hematol. 2019 Mar;94(3):358-362. doi: 10.1002/ajh.25369. Epub 2018 Dec 13. |
| 26697412 | Background | Pettit K, Odenike O. Defining and Treating Older Adults with Acute Myeloid Leukemia Who Are Ineligible for Intensive Therapies. Front Oncol. 2015 Dec 14;5:280. doi: 10.3389/fonc.2015.00280. eCollection 2015. |
| 30892988 | Background | Wei AH, Strickland SA Jr, Hou JZ, Fiedler W, Lin TL, Walter RB, Enjeti A, Tiong IS, Savona M, Lee S, Chyla B, Popovic R, Salem AH, Agarwal S, Xu T, Fakouhi KM, Humerickhouse R, Hong WJ, Hayslip J, Roboz GJ. Venetoclax Combined With Low-Dose Cytarabine for Previously Untreated Patients With Acute Myeloid Leukemia: Results From a Phase Ib/II Study. J Clin Oncol. 2019 May 20;37(15):1277-1284. doi: 10.1200/JCO.18.01600. Epub 2019 Mar 20. |
| 25987659 | Background | Dombret H, Seymour JF, Butrym A, Wierzbowska A, Selleslag D, Jang JH, Kumar R, Cavenagh J, Schuh AC, Candoni A, Recher C, Sandhu I, Bernal del Castillo T, Al-Ali HK, Martinelli G, Falantes J, Noppeney R, Stone RM, Minden MD, McIntyre H, Songer S, Lucy LM, Beach CL, Dohner H. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts. Blood. 2015 Jul 16;126(3):291-9. doi: 10.1182/blood-2015-01-621664. Epub 2015 May 18. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |