Study of Azacytidine Combined With Lenalidomide As Maintenance Therapy Based on MRD Monitoring in AML

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    60
  • sponsor
    Ge Zheng
Updated on 14 April 2022

Summary

Great progress has been witnessed on the treatment of acute myeloid leukemia (AML) in recent years. However, elderly patients ineligible for receiving high dose chemotherapy and allo-HSCT, have high relapse rate and treatment-related complications. Azacitidine (AZA), a listed hypomethylating agent in China in 2018, is the only approved demethylating drug in the treatment of AML, following the NCCN guidelines. In addition, lenalidomide(LEN) has been shown to rapidly enhance cytotoxic T- and natural killer (NK)-cell function and reduce relapse post-chemotherapy in patients with MM, also has substantial activity as a single agent in elderly patients with AML. Measurable residual disease (MRD) has been proven to be highly prognostic in quite a number clinical studies. This study is aimed to validate the efficacy and safety advantages of the maintenance therapy that contain AZA and LEN in elderly or unfit for intensive therapy patients with AML based on MRD monitoring.

Description

In this study, elderly or unfit for intensive therapy AML patients who had achieved complete remission(CR) after remission-induction and consolidation chemotherapy were assigned to 3 Arms: (1) Maintenance therapy with AZA combined with LEN(AZA+LEN): AZA 50mg/m² per day for days 1-5 and LEN 10mg per day orally for days 6-26 , every 28 days for up to 12 cycles or progression; (2) Maintenance therapy with AZA only: AZA 50mg/m² per day for days 1-5, every 28 days for up to 12 cycles or progression; (3) Observation or with supporting therapy. MRD will be assessed by flow cytometry and molecular techniques. The efficacy and safety of the 3 Arms will be evaluated in this study.

Details
Condition Acute Myeloid Leukemia in Remission
Treatment Lenalidomide, Azacitidine
Clinical Study IdentifierNCT04490707
SponsorGe Zheng
Last Modified on14 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosed with acute myeloid leukemia.Meet the criteria of the 2016 WHO classification system(APL were excluded), based on morphology, immunology, cytogenetics and molecular biology (MICM) diagnosis
Complete remission was evaluated according to 2020 NCCN guidelines after induction treatment
Patients with age≥ 60 years; or age<60 years unfit for intensive chemotherapy
Volunteered to sign the informed consent

Exclusion Criteria

Mental disorders or other conditions that cannot meet the requirements of research, treatment and monitoring
Allergic to Azacytidine, Lenalidomide , or other drugs of this study
Age over 80 years
Any other conditions considered by the study investigators that are not suitable for participating in this clinical trial
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