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| Name | Class |
|---|---|
| Shenzhen Second People's Hospital | OTHER |
| The Seventh Affiliated Hospital of Sun Yat-sen University | OTHER |
| Maoming People's Hospital | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
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Up Until now, there is not well acepted treatment for relapsed/refractory (rr) acute myeloid luekemia (AML), which has low complete response and poor survival. According to different guildlines, clinical trial is the first choice for the treatment of rrAML. High expression of BCL-2 and hypermethylation are very important factors for drug resistance in AML. Lots of studies have reported combination of BCL-2 inhibitor with hypomethylating agents (HMA) showed a promising efficacy in elder or unfit patients with newly diagnosed AML, however, presented not that exciting curing effect in rrAML. It is known that overexpression of MCL-1 and BCL-XL is the main reason for leukemia cells being resistant to BCL2 inhibitors. Since Homoharringtonine (HHT) could downregulate MCL-1 and BCL-XL in leukemia cells, there might be a synergic effect for combination of BCL-2 inhibitors with HHT, which has been proven in the treatment of lymphoma. Yet, there is not a report for the use of this combination in AML. In this single arm multi-centers prospective study, adult patients with rrAML are included and treated with BCL-2 inhibitor venetoclax at a dose of 400mg per day for 14 days, combined with azacitidine (AZA) at a dose of 75mg/m2 per day for 7 days, and HHT 1mg/m2 per day for 7 days, and then the eficacy and safety of HVA regimens as salvage treatment in rrAML are assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HVA treatment | Experimental | All patients with rrAML are treated with HVA regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HVA Regimens as Salvage Treatment | Combination Product | venetoclax with a dose of 400mg per day for 14 days, combined with azacitidine (AZA) with a dose of 75mg/m2 per day for 7 days, and HHT 1mg/m2 per day for 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response | Blast rate lower than 5% with or without peripheral blood cell recover | At the end of Cycle 2 (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of HVA treatment | The number of participants experiencing 3/4 degree bone marrow suppession and infection. | At the end of Cycle 2 (each cycle is 28 days) |
| Disease-free survival |
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Inclusion Criteria:
Patients with rrAML Patients with the age of 18-65 years old
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qifa Liu | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology,Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37899297 | Derived | Yu S, Zhang Y, Yu G, Wang Y, Shao R, Du X, Xu N, Lin D, Zhao W, Zhang X, Xiao J, Sun Z, Deng L, Liang X, Zhang H, Guo Z, Dai M, Shi P, Huang F, Fan Z, Liu Q, Lin R, Jiang X, Xuan L, Liu Q, Jin H. Sorafenib plus triplet therapy with venetoclax, azacitidine and homoharringtonine for refractory/relapsed acute myeloid leukemia with FLT3-ITD: A multicenter phase 2 study. J Intern Med. 2024 Feb;295(2):216-228. doi: 10.1111/joim.13738. Epub 2023 Oct 29. | |
| 37120593 |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D004915 | Leukemia, Erythroblastic, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016879 | Salvage Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| OTHER |
| Shenzhen Hospital of Southern Medical University | OTHER |
| Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| The First People's Hospital of Chenzhou | UNKNOWN |
| Peking University Shenzhen Hospital | OTHER |
| Zhongshan People's Hospital, Guangdong, China | OTHER |
Patients with rrAML are treated with HVA regimen
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| one year |
| Overall survival | one year |
| Derived |
| Jin H, Zhang Y, Yu S, Du X, Xu N, Shao R, Lin D, Chen Y, Xiao J, Sun Z, Deng L, Liang X, Zhang H, Guo Z, Dai M, Shi P, Huang F, Fan Z, Yin Z, Xuan L, Lin R, Jiang X, Yu G, Liu Q. Venetoclax Combined with Azacitidine and Homoharringtonine in Relapsed/Refractory AML: A Multicenter, Phase 2 Trial. J Hematol Oncol. 2023 Apr 29;16(1):42. doi: 10.1186/s13045-023-01437-1. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |