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For newly diagnosed high-relapse-risk CEBPA mutant acute myeloid leukemia patients, we aim to perform allogeneic hematopoietic stem cell transplantation after patients finished one cycle of induction and two cycles of consolidation. To access whether the therapeutic regimen is effective for high-relapse-risk CEBPA mutant acute myeloid leukemia, the disease-free-survival (DFS), overall survival (OS), non-relapse-mortality of patients is evaluated.
High-relapse-risk definition:
Participants with non-bZIP in-frame mutations, WT1 mutated status or CD7 negative status are considered of high-relapse-risk; The positive threshold for flow cytometry MRD was 0.0001%; The MRD threshold of molecular biology is the lowest value of the detection protocol of the center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSCT-group | patients received allogeneic hematopoietic stem cell transplantation after consolidation treatment |
| |
| Chemo-group | patients received chemotherapy after consolidation treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | Allogeneic Hematopoietic Stem Cell Transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| disease-free-survival | disease-free-survival | from data of AML diagnosis until the data of AML relapse, assessed up to 3 years |
| The relation of CEBPA Mutant AML genetics subgroup with MRD negativity rate after chemotherapy and DFS after transplantation | The relation of CEBPA Mutant AML genetics subgroup with MRD negativity rate after chemotherapy and DFS after transplantation | from enrollment to study completion, a maximum of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| non-relapse-mortality | non-relapse-mortality | from enrollment to study completion, a maximum of 3 years |
| overall survival | overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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Patients Diagnosed in Ruijin Hospital
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiaotong University School Of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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bone marrow; peripheral blood
| Chemotherapy | Drug | Chemotherapy |
|
| from enrollment to study completion, a maximum of 3 years |
| adverse events | adverse events | from enrollment to study completion, a maximum of 3 years |
| 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 |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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