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

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

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.

Study Overview

• Status: Unknown
• Conditions: Untreated Adult Acute Myeloid Leukemia; Effect of Drugs; Drug Safety
• Intervention / Treatment: Drug: Decitabine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Decitabine, CR rate,OS,EFS,RFS; Therapeutic effect and safety of 10 days of decitabine. Acute myeloid leukemia,no acute promyelocytic leukemia.

Drug: Decitabine; 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).; Other Names: Dacogen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Jianxiang Wang
• Collaborators: Xian-Janssen Pharmaceutical Ltd.
• Investigators: Principal Investigator: Jianxiang Wang, MD, Institute of Hematology, Hospital of Blood Disease, Chinese Academy of Medical Sciences

Publications and helpful links

General Publications

• 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.

Helpful Links

• We do not have a protocol's home page. This website is our hospital's home page and introduces some information of our hospital.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ANTICIPATED): July 1, 2014
• Study Completion (ANTICIPATED): July 1, 2016

Study Registration Dates

• First Submitted: June 24, 2012
• First Submitted That Met QC Criteria: June 29, 2012
• First Posted (ESTIMATE): July 4, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 6, 2012
• Last Update Submitted That Met QC Criteria: July 4, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: elderly patient; acute myeloid leukemia; decitabine
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Decitabine
• Other Study ID Numbers: DACOGENAML2003