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

NCT ID: NCT04490707

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-12-30

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.

Conditions

Acute Myeloid Leukemia in Remission

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Azacitidine plus Lenalidomide (AZA+LEN)

Arm 1(AZA+LEN): Elderly or unfit for intensive therapy AML patients who had achieved CR after remission-induction and consolidation chemotherapy enter maintenance therapy with AZA combined with 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.

AZA -Azacitidine, LEN- Lenalidomide

Group Type: EXPERIMENTAL

Azacitidine

Intervention Type: DRUG

Elderly or unfit for intensive therapy patients with acute myeloid leukemia who had entered CR receive maintenance therapy contained Azacitidine

Lenalidomide

Intervention Type: DRUG

Elderly or unfit for intensive therapy patients with acute myeloid leukemia who had entered CR receive maintenance therapy contained Lenalidomide

Azacitidine(AZA)

Arm 2 (AZA): Elderly or unfit for intensive therapy AML patients who had achieved CR after remission-induction and consolidation chemotherapy enter maintenance therapy with AZA 50mg/m² per day for days 1-5, every 28 days for up to 12 cycles or progression.

AZA -Azacitidine

Group Type: EXPERIMENTAL

Azacitidine

Intervention Type: DRUG

Elderly or unfit for intensive therapy patients with acute myeloid leukemia who had entered CR receive maintenance therapy contained Azacitidine

Observation

Arm 3(Observation): Elderly or unfit for intensive therapy AML patients who had achieved CR after remission-induction and consolidation chemotherapy enter observation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Azacitidine

Elderly or unfit for intensive therapy patients with acute myeloid leukemia who had entered CR receive maintenance therapy contained Azacitidine

Intervention Type: DRUG

Lenalidomide

Elderly or unfit for intensive therapy patients with acute myeloid leukemia who had entered CR receive maintenance therapy contained Lenalidomide

Intervention Type: DRUG

Other Intervention Names

AZA; LEN

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ge Zheng

OTHER

Sponsor Role: lead

Responsible Party

Ge Zheng

Director of Department of Hematology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zheng Ge, M.D, Ph.D

Role: STUDY_DIRECTOR

Zhongda Hospital

Locations

Department of Hematology, Zhongda Hospital Southeast University, Institute of Hematology Southeast University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zheng Ge, M.D, Ph.D

Role: CONTACT

Janege879@hotmail.com

02583262468

Facility Contacts

Zheng Ge, M.D, Ph.D

Role: primary

Janege879@hotmail.com

02583262468

Other Identifiers

ZDYYGZ202005

Identifier Type: -

Identifier Source: org_study_id