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| Name | Class |
|---|---|
| Nanfang Hospital, Southern Medical University | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
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This study intends to use a randomized controlled design to compare the MRD-negativw rate and related efficacy and safety of venetoclax combined with intermediate-dose cytarabine (IDAC) versus IDAC in the consolidation treatment of patients with AML after remission, providing high-quality evidence-based medical evidence for optimizing post-remission consolidation therapy for AML and improving patients' prognosis.
Studies have shown that venetoclax can significantly enhance the efficacy of intensive chemotherapy (IC) in the induction and salvage treatment of AML. However, there is still a lack of direct comparison of the efficacy and safety of venetoclax combined with intermediate-dose cytarabine (IDAC) with IDAC for consolidation in AML. In order to evaluate the benefit of venetoclax combined with IDAC, we plan to conduct a multicenter, prospective randomized controlled, phase 2 study to compare the efficacy and safety of venetoclax (d1-7, 400mg QD) combined with cytarabine (d1-3, 1.5g/㎡, q12h) versus cytarabine only for consolidation therapy in AML, aiming to fill the current evidence gap and provide scientific basis for improving deeper remission of AML and finally improve patients' long-term survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VEN+IDAC | Experimental | Venetoclax 400mg per day from day 1 to day 7; cytarabine 1.5g/m^2 q12h from day 1 to day 3. |
|
| IDAC | Active Comparator | Cytarabine 1.5g/m^2 q12h from day 1 to day 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventoclax | Drug | Venetoclax 400mg per day from day 1 to day 7 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Measurable residual disease (MRD) negative | MRD is monitored using flow cytometric analysis with a positive MRD threshold of 0.1%. | At the end of cycle 2 (28 days for a cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Recurrence (CIR) | Assess the risk of leukemia recurrence after the consolidation | 2 years |
| Overall survival (OS) | OS is calculated from enrollment to death or the last follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology, Guangdong Second Provincial General Hospital | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Guangzhou First People's Hospital | OTHER |
| Dongguan People's Hospital | OTHER_GOV |
| Zhongshan People's Hospital, Guangdong, China | OTHER |
| Shunde Hospital, Sothen Medical University | UNKNOWN |
| Shenzhen Second People's Hospital | OTHER |
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| Cytarabine |
| Drug |
Cytarabine 1.5g/m^2 q12h from day 1 to day 3. |
|
| 2 years |
| Disease Free Survival (DFS) | It refers to the time from the start of the consolidation to disease recurrence or death from any cause or the last follow-up. | 2 years |
| Aderse events | Side effects of the consolidations including haematological and non-haematological toxicity. | At the end of cycle 2 (28 days for a cycle) |
| The rate of being bridged to allogeneic hematopoietic stem cell transplantation | To assess how many patients are needed to accept allogeneic hematopoietic stem cell transplantation after the consolidation. | 2 years |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |