Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients

NCT06379360 | Active Not Recruiting Phase 2

• 1 other identifier: SZAMLLRM01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

HMA maintenance therapy is expected to benefit overall survival (OS) and relapse free survival (RFS) in AML patients with favorable risk.

Conditions

Acute Myeloid Leukemia

Keywords

AML; favorable risk; azacitidine; decitabine; maintenance therapy

Outcome Measures

Primary Outcomes (1)

• Relapse free survival (RFS)

  It is measured from the date of entry into this trial to the date of hematologic relapse or death from any cause; subjects not known to have any of these events are censored on the date they were last examined.

  5 year

Secondary Outcomes (2)

• Overall survival (OS)

  5 year

• Cumulative incidence of relapse (CIR)

  5 year

Study Arms (1)

HMA maintenance therapy

EXPERIMENTAL

All enrolled patients received maintenance therapy consisting of azacitidine or decitabine.

Drug: Hypomethylating agent, Azacitidine or Decitabine

Interventions

Hypomethylating agent, Azacitidine or Decitabine DRUG

All enrolled patients received maintenance therapy consisting of Azacitidine (75mg/m2, subcutaneous injection, days 1-7) or Decitabine (20mg/m2, intravenous infusion, days 1-5), every three months as a cycle, for a maintenance therapy of 4-8 cycles.

Also known as: Hypomethylating agent (HMA)

HMA maintenance therapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥16 years;
• Patients diagnosed with AML and categorized into favorable-risk group according to European LeukemiaNet (ELN) 2017;
• Patients achieved remission after induction therapy and completed at least 3 cycles of high-dose cytarabine-based consolidation therapy, remaining in FCM-MRD-negative remission at enrollment. FCM-MRD was assessed by multiparameter flow cytometry, in accordance with expert consensus from China, with MRD positivity defined as ≥0.1%.
• Patients not receiving hematopoietic stem cell transplantation prior to enrollment;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
• Expected survival time ≥ 3 months;
• No serious heart, lung, liver or kidney disease;
• Have the ability to understand and be willing to sign the informed consent form for this trial.

You may not qualify if:

• Patients experienced hematologic relapse before recruitment.
• Patients who are allergic to the study drug or drugs with similar chemical structures.
• Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
• Active infection.
• Active bleeding.
• Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
• Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.
• Liver function abnormalities (total bilirubin \> 1.5 times the upper limit of the normal range, Alanine Aminotransferase (ALT) / Aspartate Aminotransferase (AST) \> 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST \> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \> 1.5 times the upper limit of the normal value).
• Patients with a history of clinically significant Corrected QT Interval (QTc) prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.
• Surgery on the main organs within the past six weeks.
• Drug abuse or long-term alcohol abuse that would affect the evaluation results. Patients who have received organ transplants (excepting bone marrow transplantation).
• Patients not suitable for the study according to the investigator's assessment.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• Canglang Hospital of Suzhou: collaborator
• The Second People's Hospital of Huai'an: collaborator
• Suzhou Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine; Decitabine

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

Study Officials

• Sheng-Li Xue, M.D.

  The First Affliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Apply hypomethylating agent, azacitidine or decitabine as maintenance therapy.

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: July 1, 2019
• Primary Completion: July 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 21, 2026

Record last verified: 2026-03

Locations

CN (1)