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Completed

NCT Number: NCT02936089

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Risk Stratification

Age range

14 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. overall survival (OS)

    Time frame: 3 year

Secondary outcomes

  1. leukemia relapse rate

    Time frame: 3 year

  2. disease-free survival (DFS)

    Time frame: 3 year

  3. event Free Survival (EFS)

    Time frame: 3 year

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • Zhujiang Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Oct 18, 2016
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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