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

NCT04490707 | Unknown Phase 3 DMC

• 1 other identifier: ZDYYGZ202005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia in Remission

Keywords

Acute myeloid leukemia; Azacitidine; Lenalidomide; Maintenance Therapy; MRD

Outcome Measures

Primary Outcomes (2)

• DFS

  DFS in months, in present of disease free survival period of all participants

  From date of randomization or complete remission until the date of first documented disease progression from any cause,assessed up to 100weeks

• OS

  OS in months, in present of over all survival period of all participants

  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 (1)

• Adverse events rates

  From date of randomization or initial treatment until the end date of the study, assessed up to 100 weeks

Study Arms (3)

Azacitidine plus Lenalidomide (AZA+LEN)

EXPERIMENTAL

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

Drug: Azacitidine; Drug: Lenalidomide

Azacitidine(AZA)

EXPERIMENTAL

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

Drug: Azacitidine

Observation

NO INTERVENTION

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

Interventions

Azacitidine DRUG

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

Also known as: AZA

Azacitidine plus Lenalidomide (AZA+LEN); Azacitidine(AZA)

Lenalidomide DRUG

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

Also known as: LEN

Azacitidine plus Lenalidomide (AZA+LEN)

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ge Zheng: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine; Lenalidomide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Zheng Ge, M.D, Ph.D

  Zhongda Hospital

  STUDY DIRECTOR

Central Study Contacts

Zheng Ge, M.D, Ph.D

CONTACT

02583262468; Janege879@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Department of Hematology

Study Record Dates

• First Submitted: July 26, 2020
• First Posted: July 29, 2020
• Study Start: September 1, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)