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Recruiting NCT06379360

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

Phase II Interventional Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hypomethylating agent, Azacitidine or Decitabine.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients: A Single Arm, Multi Center Clinical Trial

Overview

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

Detailed description

Applying hypomethylating agents, azacitidine or decitabine as maintenance therapy in favorable-risk AML may prolong the remission duration and further improve their long-term survival.

Interventions

  • Drug Hypomethylating agent, Azacitidine or Decitabine
    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.

Primary outcome measures

  • Relapse free survival (RFS) [Time frame: 5 year]
Secondary outcome measures (2)
  • Overall survival (OS) [Time frame: 5 year]
  • Cumulative incidence of relapse (CIR) [Time frame: 5 year]

Eligibility criteria

Inclusion criteria

  • Patients aged ≥16 years;
  • Patients diagnosed with AML and categorized into favorable-risk group according to European LeukemiaNet (ELN) 2022;
  • Patients achieved remission after induction therapy and finished at least 3 cycles of high-dose Aar-C based consolidation therapy, remaining in minimal residual disease (MRD) negative remission status (For NPM1-mutated and core binding factor acute myeloid leukemia (CBF-AML), MRD negative is defined as <2%, CEBPA-mutated AML, MRD negative is 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT06379360 · SZAMLLRM01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗