Overview

This trial is active, not recruiting.

Conditions untreated adult acute myeloid leukemia, effect of drugs, drug safety
Treatment decitabine
Phase phase 3
Sponsor Jianxiang Wang
Collaborator Xian-Janssen Pharmaceutical Ltd.
Start date May 2012
End date July 2014
Trial size 46 participants
Trial identifier NCT01633099, DACOGENAML2003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Therapeutic effect and safety of 10 days of decitabine. Acute myeloid leukemia,no acute promyelocytic leukemia.
decitabine Dacogen
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).

Primary Outcomes

Measure
Complete response rate after induction chemotherapy with decitabine
time frame: 21 days after the induction chemotherapy
Overall survival rate
time frame: Up to 46 months after inclusion
Event free survival rate
time frame: Up to 46 months after inclusion
Relapse free survival rate
time frame: Up to 46 months after inclusion

Secondary Outcomes

Measure
Adverse events of decitabine for elderly AML patients
time frame: Up to 46 months
Weight of elderly AML patients
time frame: Up to 46 months
ECOG(Eastern Cooperative Oncology Group) score for elderly AML patients
time frame: Up to 46 months
Physical examination of decitabine for elderly AML patients
time frame: Up to 46 months
Blood pressure of elderly AML patients
time frame: Up to 46 months
Respiratory rate of elderly AML patients
time frame: Up to 46 months
Heart rate of elderly AML patients
time frame: Up to 46 months
Body temperature of elderly AML patients
time frame: Up to 46 months
ECG of elderly AML patients
time frame: Up to 46 months
Bone marrow condition of elderly AML patients
time frame: Up to 46 months

Eligibility Criteria

Male or female participants at least 60 years old.

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.

Additional Information

Official title The Clinical Research About the Therapeutic Effect and Safety of 10 Days Regimen With Single-agent of Decitabine for Elderly AML Patients
Principal investigator Jianxiang Wang, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Chinese Academy of Medical Sciences.