Untreated Adult Acute Myeloid Leukemia Clinical Trial
Official title:
The Clinical Research About the Therapeutic Effect and Safety of 10 Days Regimen With Single-agent of Decitabine for Elderly AML Patients
Verified date | July 2012 |
Source | Chinese Academy of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Unknown status |
Enrollment | 46 |
Est. completion date | July 2016 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility |
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Jianxiang Wang | Xian-Janssen Pharmaceutical Ltd. |
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete response rate after induction chemotherapy with decitabine | 21 days after the induction chemotherapy | ||
Primary | Overall survival rate | Up to 46 months after inclusion | ||
Primary | Event free survival rate | Up to 46 months after inclusion | ||
Primary | Relapse free survival rate | Up to 46 months after inclusion | ||
Secondary | Adverse events of decitabine for elderly AML patients | Up to 46 months | ||
Secondary | Weight of elderly AML patients | Up to 46 months | ||
Secondary | ECOG(Eastern Cooperative Oncology Group) score for elderly AML patients | Up to 46 months | ||
Secondary | Physical examination of decitabine for elderly AML patients | Up to 46 months | ||
Secondary | Blood pressure of elderly AML patients | Up to 46 months | ||
Secondary | Respiratory rate of elderly AML patients | Up to 46 months | ||
Secondary | Heart rate of elderly AML patients | Up to 46 months | ||
Secondary | Body temperature of elderly AML patients | Up to 46 months | ||
Secondary | ECG of elderly AML patients | Up to 46 months | ||
Secondary | Bone marrow condition of elderly AML patients | Up to 46 months |
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