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| Name | Class |
|---|---|
| Guangzhou First People's Hospital | OTHER |
| Zhujiang Hospital | OTHER |
| Peking University People's Hospital | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
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Acute myeloid leukemia(AML) patients with favorable and intermediate cytogenetics at diagnosis are generally excluded from first-line allo-SCT. However, these patients may eventually relapse in some cases. Our previous study found that stratification of treatment based on cytogenetics and therapeutic response could benefit low and intermediate AML. To further verify the results, we conducted a prospective multi-center study. The purpose of this study is to establish risk stratification based on cytogenetics and minimal-residual-disease (MRD) analysis to determine whether a MRD-directed therapy for low and intermediate AML patients has positive results in terms of overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRD-directed therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRD-directed therapy | Combination Product | The purpose of this study is to establish risk stratification based on cytogenetics at diagnosis and MRD analysis after induction chemotherapy and before consolidation chemotherapy to determine whether a MRD directed therapy for low and intermediate AML patients has positive results in terms of overall survival. |
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival (DFS) | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| leukemia relapse rate | 3 year | |
| disease-free survival (DFS) | 3 year | |
| overall survival (OS) |
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Inclusion Criteria:
Low-risk and intermediate-risk AML Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion Criteria:
Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) Patients with any conditions not suitable for the trial (investigators' decision)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | 510515 | 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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| OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
MRD-directed therapy
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|
| 3 year |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |