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To compare the efficacy and safty of ABC-14 regimen with the traditional "3+7" regimen or AB-14 regimen in the treatment of newly diagnosed acute myeloid leukaemia
Acute myeloid leukemia (AML) is a clonal malignant blood disease with genetic heterogeneity and originated from hematopoietic stem progenitor cells.In the past 50 years, the "3+7" induction regimen represented by cytotoxic drugs (including anthracyclines/anthraquinones combined with cytarabine) has remained the standard induction regimen for newly diagnosed AML patients with intensive chemotherapy. In AML patients <60 years old, the "3+7" regimen induces a complete response rate of 60% to 80%, but the treatment-related mortality is as high as 13%, and more than half of the patients face the threat of relapse, and the 5-year overall survival rate is about 35% to 40%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABC-14 regimen | Experimental | AZA,Venetoclax,Chidamide |
|
| 3+7 chemotherapy regimen | Active Comparator | Daunorubicin/idarubicin/mitoxantrone and cytarabine |
|
| AB-14 regimen | Active Comparator | AZA,Venetoclax |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide | Drug | Induction Therapy |
| |
| Venetoclax |
| Measure | Description | Time Frame |
|---|---|---|
| Composite complete remission (CRc) | composite complete remission,CRc: CR + CRi + MLFS | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of MRD turn negative | minimal residual disease turn negative | 6 months |
| DoR | Duration of remission | 2 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianyu Weng | Contact | 020-83827812 | wengjianyu@gdph.org.cn | |
| Du Xin | Contact | 020-83827812 | xind@gdph.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jianyu Weng | Guangdong Provincial People Hosptial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguan General Hosptial | Recruiting | Dongguan | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41366419 | Derived | Yan H, Huang X, Wu P, Deng C, Li M, Lai P, Du X, Weng J. Comparing the efficacy and safety of the ABC-14 regimen (azacitidine, venetoclax, and chidamide) with traditional "3 + 7" intensive induction regimen or AB-14 regimen (venetoclax combined with azacitidine) in newly diagnosed AML: study protocol for a prospective, multicenter, randomized, open-label clinical trial. Trials. 2025 Dec 10;27(1):38. doi: 10.1186/s13063-025-09339-y. |
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| Drug |
Induction Therapy |
|
| azacitidine | Drug | Induction Therapy |
|
| Anthracyclines or anthraquinones | Drug | Induction Therapy |
|
|
| cytarabine | Drug | Induction Therapy |
|
| RFS | Relapsed-free survival | 1 year |
| OS | Overall survival | 1 year |
| AE | Incidence of of grade 3-4 adverse events/Duration of severe myelosuppression/ Incidence of severe infection/Treatment-related mortality, according to Common Terminology Criteria for Adverse Events, versions 5.0 | Throughout the study until the end, up to 2 years |
| Foshan First People's Hospital | Recruiting | Foshan | Guangdong | China |
|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | China |
|
| The Fifth Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
|
| The First Affiliated Hospital of Guangdong Pharmaceutical University | Recruiting | Guangzhou | Guangdong | China |
|
| The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
|
| The First Affiliated Hospital of Jinan University | Recruiting | Guangzhou | Guangdong | China |
|
| The Second Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
|
| Shenzhen second people's Hospital | Recruiting | Shenzhen | Guangdong | China |
|
| Affiliated Hospital of Guangdong Medical University | Recruiting | Zhanjiang | Guangdong | China |
|
| Zhuhai General Hosptial | Recruiting | Zhuhai | Guangdong | China |
|
| Hainan General Hosptial | Recruiting | Haikou | Hainan | China |
|
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| C579720 | venetoclax |
| D001374 | Azacitidine |
| D018943 | Anthracyclines |
| D000880 | Anthraquinones |
| D015255 | Idarubicin |
| D003630 | Daunorubicin |
| D008942 | Mitoxantrone |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011809 | Quinones |
| D001087 | Arabinonucleosides |
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