Overview

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

Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ge Zheng
Treatments:
Azacitidine
Lenalidomide
Criteria
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 ageā‰„ 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.