NCT06379360Active, not recruitingPhase 2
Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients: A Single Arm, Multi Center Clinical Trial
The First Affiliated Hospital of Soochow University1 site in 1 country60 target enrollmentStarted: July 1, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Relapse free survival (RFS)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
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.
Arms & Interventions
HMA maintenance therapy
Experimental
All enrolled patients received maintenance therapy consisting of azacitidine or decitabine.
Intervention: Hypomethylating agent, Azacitidine or Decitabine (Drug)
Outcomes
Primary Outcomes
Relapse free survival (RFS)
Time Frame: 5 year
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.
Secondary Outcomes
- Cumulative incidence of relapse (CIR)(5 year)
- Overall survival (OS)(5 year)
Investigators
Sheng-Li Xue, MD
Principal Investigator
The First Affiliated Hospital of Soochow University
Study Sites (1)
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