Acute Myeloid Leukemia
First Hospital of Jilin University
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: Decitabine20 mg/m2/day for 5 days
- Drug: Daunorubicin, CytarabineDaunorubicin: 45 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days
- Drug: Mitoxantrone, CytarabineMitoxantrone: 8 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days
- Drug: Aclacinomycin, CytarabineAclacinomycin: 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|
- 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.
- 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.
- First Hospital of Jilin UniversityNot specifiedChangchun, Jilin, China, 130021
active not recruiting
31 December, 2016
17 January, 2017