Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Zhujiang Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Acute myeloid leukemia with t(8;21) /AML1-ETO-positive (AE AML) is a heterogeneous disease entailing different prognoses. There were significant differences in the therapeutic effect between different subgroups of AE AML. Therefore, risk stratification-directed therapy is very necessary for AE AML.
Acute myeloid leukemia with t(8;21) /AML1-ETO-positive (AE AML) is a heterogeneous disease entailing different prognoses.There were significant differences in the therapeutic effect between different subgroups of AE AML. For example, patients with c-kit mutation had higher relapse rate and lower overall survival, compared with those without c-kit mutation. Therefore, risk stratification-directed therapy is very necessary for AE AML. The purpose of this study is to establish risk stratification-directed therapy for AE AML.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low risk group | Experimental | Patients with KIT-ASXL1- (non-mutation, NM) and acquiring main molecular response (MMR) after two cycles of consolidation. |
|
| Intermediate risk group | Experimental | Patients with KIT+/ASXL1+ (single mutation, 1M) and acquiring MMR after two cycles of consolidation. |
|
| High risk group | Experimental | Patients with KIT+ASXL1+ (two mutations ,2M) or without acquiring MMR after two cycles of consolidation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consolidation with chemotherapy (CT) or autologous hematopoietic stem cell transplantation (auto-HSCT) | Other | For CT, patients were treated with high dose cytarabine (HDAC), cytarabine at a dosage of 1-3 g/m2 q12 h ×6 doses, for 4-6 cycles. For auto-HSCT, patients were treated with 3 cycles of HDAC and then bridged to auto-HSCT. |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| leukemia relapse rate | 3 year | |
| disease-free survival (DFS) | 3 year | |
| event Free Survival (EFS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dan Xu | Nanfang Hospital, Southern Medical University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37957175 | Derived | Xu D, Yang Y, Yin Z, Tu S, Nie D, Li Y, Huang Z, Sun Q, Huang C, Nie X, Yao Z, Shi P, Zhang Y, Jiang X, Liu Q, Yu G. Risk-directed therapy based on genetics and MRD improves the outcomes of AML1-ETO-positive AML patients, a multi-center prospective cohort study. Blood Cancer J. 2023 Nov 13;13(1):168. doi: 10.1038/s41408-023-00941-4. No abstract available. |
Not provided
Not provided
All collected IPD, all IPD that underlie results will be shared in a publication. For the detail, those who are interested in can contact the authors.
The data will be available after being published, for at least five years.
All collected IPD, all IPD that underlie results will be shared in a publication. For the detail, those who are interested in can contact the authors.
Not provided
Not provided
Patients with newly diagnosed AML1/ETO-positive AML took risk-directed stratification therapy based on c-KIT and ASXL1 mutations and measurable residual disease (MRD). low risk (LR) group (KIT-ASXL1- with main molecular response (MMR)) was recommended to chemotherapy (CT) or autologous hematopoietic stem cell transplantation (auto-HSCT). Intermediate risk (IR) group (KIT+/ASXL1+ with MMR) was suggested for auto-HSCT or HLA-matched HSCT. High risk (HR) group (KIT+ASXL1+ or without MMR) was treated with allogeneic (allo-) HSCT.
Not provided
Not provided
Not provided
Not provided
|
| Consolidation with auto-HSCT or HLA-matched HSCT | Other | For auto-HSCT, patients were treated with 3 cycles of HDAC and then bridged to auto-HSCT. For HLA-matched HSCT, patients were treated with 1-2 cycles of HDAC and then bridged to HLA-matched HSCT. HLA-matched donors were available in these patients. |
|
| allogeneic HSCT | Other | For allogeneic HSCT, patients were treated with 1-2 cycles of HDAC and then bridged to allogeneic HSCT, including HLA-matched and haploidentical transplantation. |
|
| 3 year |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided