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Trial Title:
Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients
NCT ID:
NCT06379360
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Azacitidine
Decitabine
Conditions: Keywords:
AML
favorable risk
azacitidine
decitabine
maintenance therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Apply hypomethylating agent, azacitidine or decitabine as maintenance therapy.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Hypomethylating agent, Azacitidine or Decitabine
Description:
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.
Arm group label:
HMA maintenance therapy
Other name:
Hypomethylating agent (HMA)
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients aged ≥16 years;
2. Patients diagnosed with AML and categorized into favorable-risk group according to
European LeukemiaNet (ELN) 2022;
3. 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%).
4. Patients not receiving hematopoietic stem cell transplantation prior to enrollment;
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
6. Expected survival time ≥ 3 months;
7. No serious heart, lung, liver or kidney disease;
8. Have the ability to understand and be willing to sign the informed consent form for
this trial.
Exclusion Criteria:
1. Patients experienced hematologic relapse before recruitment.
2. Patients who are allergic to the study drug or drugs with similar chemical
structures.
3. Pregnant or lactating women, and women of childbearing age who do not want to
practice effective methods of contraception.
4. Active infection.
5. Active bleeding.
6. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a
medical history within one year before enrollment.
7. 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.
8. 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).
9. 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.
10. Surgery on the main organs within the past six weeks.
11. Drug abuse or long-term alcohol abuse that would affect the evaluation results.
Patients who have received organ transplants (excepting bone marrow
transplantation).
12. Patients not suitable for the study according to the investigator's assessment.
Gender:
All
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Sheng-Li Xue, M.D.
Phone:
+86 512 6778 1139
Email:
slxue@suda.edu.cn
Start date:
November 1, 2020
Completion date:
December 31, 2028
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06379360
