Status:
UNKNOWN
Study of Azacytidine Combined With Lenalidomide As Maintenance Therapy Based on MRD Monitoring in AML
Lead Sponsor:
Ge Zheng
Conditions:
Acute Myeloid Leukemia in Remission
Eligibility:
All Genders
60-80 years
Phase:
PHASE3
Brief 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 r...
Detailed 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) Mainten...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04490707
Start Date
September 1 2020
End Date
December 30 2022
Last Update
March 24 2022
Active Locations (1)
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1
Department of Hematology, Zhongda Hospital Southeast University, Institute of Hematology Southeast University
Nanjing, Jiangsu, China, 210009