An interventional study of Consolidation with chemotherapy (CT) or autologous hematopoietic stem cell transplantation (auto-HSCT) and Consolidation with auto-HSCT or HLA-matched HSCT in Acute Myeloid Leukemia and Risk Stratification, sponsored by Nanfang Hospital, Southern Medical University. Completed. Open to participants aged 14 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-08-08.
Sponsored by Nanfang Hospital, Southern Medical University · Not applicable, Interventional, and Treatment
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 207 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.
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Exclusion Criteria:
Patients with KIT-ASXL1- (non-mutation, NM) and acquiring main molecular response (MMR) after two cycles of consolidation.
Other: Consolidation with chemotherapy (CT) or autologous hematopoietic stem cell transplantation (auto-HSCT)
Patients with KIT+/ASXL1+ (single mutation, 1M) and acquiring MMR after two cycles of consolidation.
Other: Consolidation with auto-HSCT or HLA-matched HSCT
Patients with KIT+ASXL1+ (two mutations ,2M) or without acquiring MMR after two cycles of consolidation.
Other: allogeneic HSCT
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.
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.
For allogeneic HSCT, patients were treated with 1-2 cycles of HDAC and then bridged to allogeneic HSCT, including HLA-matched and haploidentical transplantation.
overall survival (OS)
Time frame: 3 year
leukemia relapse rate
Time frame: 3 year
disease-free survival (DFS)
Time frame: 3 year
event Free Survival (EFS)
Time frame: 3 year
No study locations are listed for this record.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Nanfang Hospital, Southern Medical University