Therapeutic Effect and Safety Study of Decitabine in Elderly Acute Myeloid Leukemia Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the safety and the therapeutic effect of Decitabine in the treatment of elderly Acute Myeloid Leukemia (AML) patients.

Detailed Description
-----------------
The outcome of the elderly AML patients is very poor. No obvious progress was achieved in this field. Decitabine is a kind of specific DNA methylation shift enzyme inhibitor. It can reverse the DNA methylation and induce the differentiation and apoptosis of the tumor cells. Recent studies about decitabine in the treatment for elderly AML patients had achieved inspiring results and indicated that low dose decitabine maybe a good choice for elderly AML patients. So in this research the investigators plan to evaluate the safety and the therapeutic effect of decitabine in the treatment of elderly AML patients.

Official Title
-----------------
The Clinical Research About the Therapeutic Effect and Safety of 10 Days Regimen With Single-agent of Decitabine for Elderly AML Patients

Conditions
-----------------
Untreated Adult Acute Myeloid Leukemia, Effect of Drugs, Drug Safety

Intervention / Treatment
-----------------
* Drug: Decitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of acute myeloid leukemia.De novo or secondary AML. Age >= 60years,female and male. Before the enrollment，WBC < 40×10E9/L，Plt > 20×10E9/L（Hydroxyurea is permitted.） In 2 weeks before the enrollment，total bilirubin < 1.5×ULN，ALT < 2.5×ULN；GGT < 2.5×ULN ，Scr < 2.0×ULN or creatinine clearance rate ≥ 50 ml/min（Cockroft-Gault）. Before the enrollment，patients must be free from the toxicity caused by the former treatment.Received no chemotherapy in the last 4 weeks and no nitrosourea in the last 6 weeks. Contraception must be taken to avoid pregnancy during the study. ECOG 0,1, or 2, predicted lifetime longer than 12 weeks. Patients must sign the informed consent prior to any study related screening procedures being performed. Exclusion Criteria: Acute promyelocytic leukemia. Chromosome and genetic abnormalities related with t（8; 21）、inv（16）、t（15; 17）. Central nervous system leukemia. Bone marrow dry tap. Patients received stem cell transplantation or chemotherapy containing azacitidine,cytarabine or decitabine in last one year, radiation therapy in last 14 days,lenalidomide in 30 days before included. Patients suffered from autoimmune hemolytic anemia or immune thrombocytopenia. Patients suffered from non-leukemia related comorbidities that will cause dysfunction of organs. Patients suffered from unstable angina or （NYHA）3/4 Congestive heart failure. Patients suffered from chronic respiratory disease and needed continued oxygen. Other active malignancy. Active HBV,HCV or AIDS patients. Uncontrolled virus or bacterium infection. The investigator believe that patients who are not suitable for this trial. Severe mental or body disorders which will interfere the research such as uncontrolled heart,lung diseases,diabetes,etc. Allergic to decitabine or its accessory. Patients received other researches in last 30 days. Without contraception. Complications causing organ dysfunction which are not caused by AML.

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Decitabine, CR rate,OS,EFS,RFS<br>Therapeutic effect and safety of 10 days of decitabine. Acute myeloid leukemia,no acute promyelocytic leukemia. | Drug: Decitabine<br>* Number of Cycles: 4 cycles. Dose and drug delivery(decitabine): The 1st cycle: 20 mg/m2, (iv,>1 hour) d1-10 of each 28 day cycle. The 2nd-4th cycle:If bone marrow blast cells≥5%, the following cycle is the same as the 1st cycle. If bone marrow blast cells<5%, the following cycle:decitabine 20 mg/m2, (iv,>1h) on d1-5 of each 28 day cycle. If Grade 4 neutropenia（<0.5×10E9/L）come arise after 5 days' cycle of decitabine and lasts more than 14 days in last cycle,the next cycle will decrease dose to 4 days(20 mg/m2, IV ,>1h, on d1-4 of each 28 day cycle).If Grade 4 neutropenia（<0.5×10E9/L）come arise after 4 days' cycle of decitabine and lasts more than 14 days in last cycle,the next cycle will decrease dose to 3 days(20 mg/m2, IV,>1h, on d1-3 of each 28day cycle).<br>* Other names: Dacogen;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate after induction chemotherapy with decitabine |  | 21 days after the induction chemotherapy | 
| Overall survival rate |  | Up to 46 months after inclusion | 
| Event free survival rate |  | Up to 46 months after inclusion | 
| Relapse free survival rate |  | Up to 46 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events of decitabine for elderly AML patients |  | Up to 46 months | 
| Weight of elderly AML patients |  | Up to 46 months | 
| ECOG(Eastern Cooperative Oncology Group) score for elderly AML patients |  | Up to 46 months | 
| Physical examination of decitabine for elderly AML patients |  | Up to 46 months | 
| Blood pressure of elderly AML patients |  | Up to 46 months | 
| Respiratory rate of elderly AML patients |  | Up to 46 months | 
| Heart rate of elderly AML patients |  | Up to 46 months | 
| Body temperature of elderly AML patients |  | Up to 46 months | 
| ECG of elderly AML patients |  | Up to 46 months | 
| Bone marrow condition of elderly AML patients |  | Up to 46 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
decitabine, acute myeloid leukemia, elderly patient