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| Name | Class |
|---|---|
| Handan Central Hospital | OTHER |
| Taian City Central Hospital | OTHER |
| Tianjin People's Hospital | OTHER |
| Guizhou Provincial People's Hospital |
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The purpose of this study is to investigate the efficacy and safety of the combination of venetoclax and HAA regimen in young, newly diagnosed acute myeloid leukemia patients under the age of 60.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The treatment group receiving the combination of venetoclax and HAA regimen. | Experimental | Received induction therapy protocol: Docetaxel (HHT) 2.5mg/㎡/day, days 3-7 Aclarubicin (Acla) 20mg/day, days 3-7 Cytarabine (Ara-c) 100mg/㎡/day, days 3-7 (given as a 24-hour infusion) Venetoclax (VEN): 100mg on day 1, 200mg on day 2, and 400mg on days 3-8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combination of venetoclax and HAA regimen | Combination Product | Using the combination of venetoclax and HAA regimen as induction therapy in young, newly diagnosed adult acute myeloid leukemia patients under the age of 60. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | which evaluates the efficacy of patient induction therapy, including complete remission (CR), complete remission with incomplete blood count recovery (CRi), and morphologic leukemia-free state (MLFS) | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal residual disease (MRD) | MRD percentage | up to 12 months |
| overall survival (OS) | Overall Survival (OS) is used to evaluate all patients enrolled in a clinical trial, from the date of enrollment until death from any cause or the date of last follow-up for surviving patients. |
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Inclusion Criteria:
The eligible subjects for enrollment in this study must meet all of the following criteria:
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from this study:
9. Participants deemed unsuitable for inclusion by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZePing Zhou, Dr | Contact | 18788571605 | zhouzeping@kmmu.edu.cn | |
| yaxian tan | Contact | 18208821198 | 353964619@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| DanQi Deng | The Second Affiliated Hospital, Kunming Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Kunming Medical University. | Recruiting | 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 |
| Second Xiangya Hospital of Central South University | OTHER |
| Western War Zone General Hospital | UNKNOWN |
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| up to 12 months |
| relapse-free survival (RFS) | Relapse-Free Survival (RFS) is only used to evaluate patients who achieve complete remission (CR) through reinduction therapy. RFS is defined as the time from achievement of CR until death from any cause, relapse, or the date of last follow-up. | up to 12 months |
| 30-day mortality rate | The 30-day mortality rate is used to evaluate all patients enrolled in a clinical trial, and is defined as the percentage of patients who die within 30 days of starting chemotherapy. | Within 30 days after starting the medication |
| adverse drug reactions | Adverse drug reactions during chemotherapy and follow-up | up to 12 months |
| 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. |
| 32786187 | Background | DiNardo CD, Jonas BA, Pullarkat V, Thirman MJ, Garcia JS, Wei AH, Konopleva M, Dohner H, Letai A, Fenaux P, Koller E, Havelange V, Leber B, Esteve J, Wang J, Pejsa V, Hajek R, Porkka K, Illes A, Lavie D, Lemoli RM, Yamamoto K, Yoon SS, Jang JH, Yeh SP, Turgut M, Hong WJ, Zhou Y, Potluri J, Pratz KW. Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia. N Engl J Med. 2020 Aug 13;383(7):617-629. doi: 10.1056/NEJMoa2012971. |
| 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. |
| 32896301 | Background | DiNardo CD, Maiti A, Rausch CR, Pemmaraju N, Naqvi K, Daver NG, Kadia TM, Borthakur G, Ohanian M, Alvarado Y, Issa GC, Montalban-Bravo G, Short NJ, Yilmaz M, Bose P, Jabbour EJ, Takahashi K, Burger JA, Garcia-Manero G, Jain N, Kornblau SM, Thompson PA, Estrov Z, Masarova L, Sasaki K, Verstovsek S, Ferrajoli A, Weirda WG, Wang SA, Konoplev S, Chen Z, Pierce SA, Ning J, Qiao W, Ravandi F, Andreeff M, Welch JS, Kantarjian HM, Konopleva MY. 10-day decitabine with venetoclax for newly diagnosed intensive chemotherapy ineligible, and relapsed or refractory acute myeloid leukaemia: a single-centre, phase 2 trial. Lancet Haematol. 2020 Oct;7(10):e724-e736. doi: 10.1016/S2352-3026(20)30210-6. Epub 2020 Sep 5. |
| 34043428 | Background | DiNardo CD, Lachowiez CA, Takahashi K, Loghavi S, Xiao L, Kadia T, Daver N, Adeoti M, Short NJ, Sasaki K, Wang S, Borthakur G, Issa G, Maiti A, Alvarado Y, Pemmaraju N, Montalban Bravo G, Masarova L, Yilmaz M, Jain N, Andreeff M, Jabbour E, Garcia-Manero G, Kornblau S, Ravandi F, Konopleva MY, Kantarjian HM. Venetoclax Combined With FLAG-IDA Induction and Consolidation in Newly Diagnosed and Relapsed or Refractory Acute Myeloid Leukemia. J Clin Oncol. 2021 Sep 1;39(25):2768-2778. doi: 10.1200/JCO.20.03736. Epub 2021 May 27. |
| 23664707 | Background | Jin J, Wang JX, Chen FF, Wu DP, Hu J, Zhou JF, Hu JD, Wang JM, Li JY, Huang XJ, Ma J, Ji CY, Xu XP, Yu K, Ren HY, Zhou YH, Tong Y, Lou YJ, Ni WM, Tong HY, Wang HF, Mi YC, Du X, Chen BA, Shen Y, Chen Z, Chen SJ. Homoharringtonine-based induction regimens for patients with de-novo acute myeloid leukaemia: a multicentre, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2013 Jun;14(7):599-608. doi: 10.1016/S1470-2045(13)70152-9. Epub 2013 May 9. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |