Decitabine Versus Conventional Chemotherapy for Maintenance Therapy of Acute Myeloid Leukemia With t(8;21)

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: Decitabine
* Drug: Daunorubicin, Cytarabine
* Drug: Mitoxantrone, Cytarabine
* Drug: Aclacinomycin, Cytarabine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decitabine<br>Six cycles of decitabine IV over one hour at 20 mg/m2/day for 5 days, every 6 weeks | Drug: Decitabine<br>* 20 mg/m2/day for 5 days<br>|
| Active Comparator: Conventional chemotherapy<br>Four cycles of conventional chemotherapy for 5 days, every 12 weeks. conventional chemotherapy includes in: DA regimen: Daunorubicin 45 mg/m2/day for 3 days, cytarabine 100 mg/m2/day for 5 days; MA regimen: Mitoxantrone 8 mg/m2/day for 3 days, cytarabine 100 mg/m2/day for 5 days; AA regimen: Aclacinomycin 20 mg/day for 5 days, cytarabine 100 mg/m2/day for 5 days. | Drug: Daunorubicin, Cytarabine<br>* Daunorubicin: 45 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days<br>Drug: Mitoxantrone, Cytarabine<br>* Mitoxantrone: 8 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days<br>Drug: Aclacinomycin, Cytarabine<br>* Aclacinomycin: 20 mg/day for 5 days; Cytarabine: 100 mg/m2/day for 5 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse free survival |  | Three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Three years | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | From enrolling to two months after administrating the last course of decitabine or chemotherapy |