NCT02936089

Risk Stratification-directed Therapy for AML With t(8;21) /AML1-ETO+

Risk Stratification-directed Therapy for Acute Myeloid Leukemia With t(8;21) /AML1-ETO-positive

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 14 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Myeloid Leukemia
• Risk Stratification

Interventions

Type	Name	Description
OTHER	Consolidation with chemotherapy (CT) or autologous hematopoietic stem cell transplantation (auto-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.
OTHER	Consolidation with auto-HSCT or HLA-matched 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.
OTHER	allogeneic HSCT	For allogeneic HSCT, patients were treated with 1-2 cycles of HDAC and then bridged to allogeneic HSCT, including HLA-matched and haploidentical transplantation.

Timeline

• Start date: 2016-10-01
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2016-10-18
• Last updated: 2023-08-08