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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02936089
• Other study ID #: NFEC-2017-168
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2023
• Source: Nanfang Hospital, Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

Inclusion Criteria:

• AE AML aged 14-70
• No abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
• Expected survival time is more than 2 months

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)

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Risk Stratification

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University	Zhujiang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival (OS)		3 year
Secondary	leukemia relapse rate		3 year
Secondary	disease-free survival (DFS)		3 year
Secondary	event Free Survival (EFS)		3 year