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A Prospective, Randomized, Controlled Trial of Decitabine Versus Conventional Chemotherapy for Maintenance Therapy of Patients With Acute Myeloid Leukemia With t(8;21) (NCT03026842)

Second Hospital of Jilin University
Acute myeloid leukemia (AML) is the most common hematological malignancies in adult patients with leukemia, and t(8;21) AML accounts for a substantial proportion of AML. AML patients with t(8;21) possess a favorable outcome and 3 - 4 course high dose cytarabine (3 g/m2) is the standard consolidation therapy for these patients with a 5-year overall survival approximately 60%. In China, intermediate dose cytarabine (1 - 2 g/m2) is used for consolidation therapy due to toxicities. After 3 - 4 course cytarabine consolidation, maintenance therapy is performed with conventional chemotherapy with a 5-year overall survival approximately 60% as well. However, continuous chemotherapy may cause toxicities and inhibit patients' immune response. Exploring new drug for maintenance therapy is urgently needed. Decitabine has a potent ability to inhibit proliferation and induce apoptosis of AML1-ETO positive leukemia cell line. Furthermore, the immunomodulatory effect of decitabine was also reported by several studies. In this study, the investigators plan to carry out a prospective, multicenter, randomized, controlled trail to compare decitabine versus conventional chemotherapy for maintenance therapy of patients with AML with t(8;21). Results of this trial may optimize the treatment for AML patients with t(8;21) in the setting of intermediate dose cytarabine consolidation.
  • Drug: Decitabine
    20 mg/m2/day for 5 days
    • Drug: Daunorubicin, Cytarabine
      Daunorubicin: 45 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days
      • Drug: Mitoxantrone, Cytarabine
        Mitoxantrone: 8 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days
        • Drug: Aclacinomycin, Cytarabine
          Aclacinomycin: 20 mg/day for 5 days; Cytarabine: 100 mg/m2/day for 5 days
          Ages eligible for Study
          18 Years to 60 Years
          Genders eligible for Study
          All
          Accepts Healthy Volunteers
          No
          Inclusion Criteria:
          • Patients are adults age ≥18 and ≤60 years
          • Patients are diagnosed as AML with t(8;21)
          • Continuous complete remission after induction and consolidation therapy with 3 - 4 course high dose cytarabine (2 g/m^2)
          • Patients whose aspartate transaminase (AST)/alanine transaminase (ALT) are ≤ 2.5 times higher than the normal upper limit, total bilirubin ≤ 3.0 mg/dl, and serum creatinine ≤ 2.0 mg/dl.
          • Subjects that signed the informed consent, which indicated they understood the purpose, the procedure and potential benefits of the trial and were willing to participate in the trial.
          Exclusion Criteria:
          • Pregnant or lactating women.
          • ECOG performance status score > 2.
          • Patients are candidates for hematopoietic stem cell transplantation.
          • Patients with a history of use of azacitidine or decitabine.
          • Patients with mental or other disorders that cannot completely cooperate with the treatment or follow up.
          • Subjects that were allergic to decitabine vehicle.
          • Patients receive immunotherapy.
          • Patients also have other organ malignant tumor.
          • Participating in other clinical research in the same period.
          • The researchers estimate that patients cannot enter the clinical trial.

          1 locations

          China (1)
          • First Hospital of Jilin University
            Not specified
            Changchun, Jilin, China, 130021
          Status:
          active not recruiting
          Type:
          Interventional
          Phase:
          Start:
          31 December, 2016
          Updated:
          17 January, 2017
          Participants:
          180
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