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Completed

NCT Number: NCT02870777

MRD-directed Therapy for Low-risk and Intermediate-risk AML.

Acute myeloid leukemia(AML) patients with favorable and intermediate cytogenetics at diagnosis are generally excluded from first-line allo-SCT. However, these patients may eventually relapse in some cases. Our previous study found that stratification of treatment based on cytogenetics and therapeutic response could benefit low and intermediate AML. To further verify the results, we conducted a prospective multi-center study. The purpose of this study is to establish risk stratification based on cytogenetics and minimal-residual-disease (MRD) analysis to determine whether a MRD-directed therapy for low and intermediate AML patients has positive results in terms of overall survival.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Minimal Residual Disease Neoplasm, Residual Neoplasms Neoplasms by Histologic Type Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Low-risk and intermediate-risk AML Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

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

MRD-directed therapy

Combination Product

The purpose of this study is to establish risk stratification based on cytogenetics at diagnosis and MRD analysis after induction chemotherapy and before consolidation chemotherapy to determine whether a MRD directed therapy for low and intermediate AML patients has positive results in terms of overall survival.

Primary outcomes

  1. disease-free survival (DFS)

    Time frame: 3 year

Secondary outcomes

  1. leukemia relapse rate

    Time frame: 3 year

  2. disease-free survival (DFS)

    Time frame: 3 year

  3. overall survival (OS)

    Time frame: 3 year

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • Guangzhou First People's Hospital
  • Peking University People's Hospital
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Third Affiliated Hospital, Sun Yat-Sen University
  • Zhujiang Hospital

Registry information

Official study title

Minimal Residual Disease-directed Therapy for Low-risk and Intermediate-risk Acute Myeloid Leukemia.

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 17, 2016
Registry last updated
Mar 4, 2020

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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