Clinical trial NCT04490707: Study of Azacytidine Combined With Lenalidomide As Maintenance Therapy Based on MRD Monitoring in AML
Official title: Clinical Study of Azacytidine Combined With Lenalidomide As Maintenance Therapy Based on MRD Monitoring In Elderly or Unfit Patients With Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Myeloid Leukemia in Remission
Keywords: Acute myeloid leukemia
Azacitidine
Lenalidomide
Maintenance Therapy
MRD
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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) 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.

Eligibility 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 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.

Primary outcomes:
measure: DFS
timeFrame: From date of randomization or complete remission until the date of first documented disease progression from any cause,assessed up to 100weeks
measure: OS
timeFrame: From date of randomization until the date of first documented death from any cause or end of this study, whichever come first,assessed up to 100weeks
Secondary outcomes:
measure: Adverse events rates
timeFrame: From date of randomization or initial treatment until the end date of the study, assessed up to 100 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Hematology, Zhongda Hospital Southeast University, Institute of Hematology Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Zheng Ge, M.D, Ph.D
role: STUDY_DIRECTOR
References: