Clinical trial NCT01633099: Therapeutic Effect and Safety Study of Decitabine in Elderly Acute Myeloid Leukemia 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Untreated Adult Acute Myeloid Leukemia
Effect of Drugs
Drug Safety
Keywords: decitabine
acute myeloid leukemia
elderly patient
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Xian-Janssen Pharmaceutical Ltd.
First posted: 2012-07-04
Enrollment: 46
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of acute myeloid leukemia.De novo or secondary AML.
2. Age \>= 60years,female and male.
3. Before the enrollment，WBC \< 40×10E9/L，Plt \> 20×10E9/L（Hydroxyurea is permitted.）
4. 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）.
5. 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.
6. Contraception must be taken to avoid pregnancy during the study.
7. ECOG 0,1, or 2, predicted lifetime longer than 12 weeks.
8. Patients must sign the informed consent prior to any study related screening procedures being performed.

Exclusion Criteria:

1. Acute promyelocytic leukemia.
2. Chromosome and genetic abnormalities related with t（8; 21）、inv（16）、t（15; 17）.
3. Central nervous system leukemia.
4. Bone marrow dry tap.
5. 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.
6. Patients suffered from autoimmune hemolytic anemia or immune thrombocytopenia.
7. Patients suffered from non-leukemia related comorbidities that will cause dysfunction of organs.
8. Patients suffered from unstable angina or （NYHA）3/4 Congestive heart failure.
9. Patients suffered from chronic respiratory disease and needed continued oxygen.
10. Other active malignancy.
11. Active HBV,HCV or AIDS patients.
12. Uncontrolled virus or bacterium infection.
13. The investigator believe that patients who are not suitable for this trial.
14. Severe mental or body disorders which will interfere the research such as uncontrolled heart,lung diseases,diabetes,etc.
15. Allergic to decitabine or its accessory.
16. Patients received other researches in last 30 days.
17. Without contraception.
18. Complications causing organ dysfunction which are not caused by AML.

Primary outcomes:
measure: Complete response rate after induction chemotherapy with decitabine
timeFrame: 21 days after the induction chemotherapy
measure: Overall survival rate
timeFrame: Up to 46 months after inclusion
measure: Event free survival rate
timeFrame: Up to 46 months after inclusion
measure: Relapse free survival rate
timeFrame: Up to 46 months after inclusion
Secondary outcomes:
measure: Adverse events of decitabine for elderly AML patients
timeFrame: Up to 46 months
measure: Weight of elderly AML patients
timeFrame: Up to 46 months
measure: ECOG(Eastern Cooperative Oncology Group) score for elderly AML patients
timeFrame: Up to 46 months
measure: Physical examination of decitabine for elderly AML patients
timeFrame: Up to 46 months
measure: Blood pressure of elderly AML patients
timeFrame: Up to 46 months
measure: Respiratory rate of elderly AML patients
timeFrame: Up to 46 months
measure: Heart rate of elderly AML patients
timeFrame: Up to 46 months
measure: Body temperature of elderly AML patients
timeFrame: Up to 46 months
measure: ECG of elderly AML patients
timeFrame: Up to 46 months
measure: Bone marrow condition of elderly AML patients
timeFrame: Up to 46 months
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Hematology, Hospital of Blood Disease, Chinese Academy of Medical Sciences
name: Jianxiang Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burnett AK, Milligan D, Prentice AG, Goldstone AH, McMullin MF, Hills RK, Wheatley K. A comparison of low-dose cytarabine and hydroxyurea with or without all-trans retinoic acid for acute myeloid leukemia and high-risk myelodysplastic syndrome in patients not considered fit for intensive treatment. Cancer. 2007 Mar 15;109(6):1114-24. doi: 10.1002/cncr.22496.