MedDataX Logo

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

NCT ID: NCT01633099

Last Updated: 2012-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Untreated Adult Acute Myeloid Leukemia Effect of Drugs Drug Safety

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

decitabine acute myeloid leukemia elderly patient

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Decitabine, CR rate,OS,EFS,RFS

Therapeutic effect and safety of 10 days of decitabine. Acute myeloid leukemia,no acute promyelocytic leukemia.

Group Type OTHER

Decitabine

Intervention Type DRUG

1. Number of Cycles: 4 cycles.
2. 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Decitabine

1. Number of Cycles: 4 cycles.
2. 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).

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dacogen

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xian-Janssen Pharmaceutical Ltd.

INDUSTRY

Sponsor Role collaborator

Jianxiang Wang

UNKNOWN

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jianxiang Wang

deputy director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jianxiang Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology, Hospital of Blood Disease, Chinese Academy of Medical Sciences

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17315155 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.chinablood.com.cn/

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DACOGENAML2003

Identifier Type: -

Identifier Source: org_study_id