The Clinical Research About the Therapeutic Effect and Safety of 10 Days Regimen With Single-agent of Decitabine for Elderly AML Patients
60 Years
N/A
Both
Untreated Adult Acute Myeloid Leukemia, Effect of Drugs, Drug Safety
Trial Information
The Clinical Research About the Therapeutic Effect and Safety of 10 Days Regimen With Single-agent of Decitabine for Elderly AML Patients
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete response rate after induction chemotherapy with decitabine
Outcome Time Frame:
21 days after the induction chemotherapy
Safety Issue:
No
Principal Investigator
Jianxiang Wang, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institute of Hematology, Hospital of Blood Disease, Chinese Academy of Medical Sciences
Authority:
China: Food and Drug Administration
Study ID:
DACOGENAML2003
NCT ID:
NCT01633099
Start Date:
May 2012
Completion Date:
July 2016
Related Keywords:
- Untreated Adult Acute Myeloid Leukemia
- Effect of Drugs
- Drug Safety
- decitabine
- acute myeloid leukemia
- elderly patient
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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