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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Xian-Janssen Pharmaceutical Ltd.
Information provided by (Responsible Party):
Jianxiang Wang, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01633099
First received: June 24, 2012
Last updated: July 4, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Untreated Adult Acute Myeloid Leukemia
Effect of Drugs
Drug Safety
 Drug: Decitabine
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Clinical Research About the Therapeutic Effect and Safety of 10 Days Regimen With Single-agent of Decitabine for Elderly AML Patients

Resource links provided by NLM:

Drug Information available for: Decitabine
U.S. FDA Resources

Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Complete response rate after induction chemotherapy with decitabine [ Time Frame: 21 days after the induction chemotherapy ] [ Designated as safety issue: No ]
  • Overall survival rate [ Time Frame: Up to 46 months after inclusion ] [ Designated as safety issue: No ]
  • Event free survival rate [ Time Frame: Up to 46 months after inclusion ] [ Designated as safety issue: No ]
  • Relapse free survival rate [ Time Frame: Up to 46 months after inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events of decitabine for elderly AML patients [ Time Frame: Up to 46 months ] [ Designated as safety issue: Yes ]
  • Weight of elderly AML patients [ Time Frame: Up to 46 months ] [ Designated as safety issue: Yes ]
  • ECOG(Eastern Cooperative Oncology Group) score for elderly AML patients [ Time Frame: Up to 46 months ] [ Designated as safety issue: Yes ]
  • Physical examination of decitabine for elderly AML patients [ Time Frame: Up to 46 months ] [ Designated as safety issue: Yes ]
  • Blood pressure of elderly AML patients [ Time Frame: Up to 46 months ] [ Designated as safety issue: Yes ]
  • Respiratory rate of elderly AML patients [ Time Frame: Up to 46 months ] [ Designated as safety issue: Yes ]
  • Heart rate of elderly AML patients [ Time Frame: Up to 46 months ] [ Designated as safety issue: Yes ]
  • Body temperature of elderly AML patients [ Time Frame: Up to 46 months ] [ Designated as safety issue: Yes ]
  • ECG of elderly AML patients [ Time Frame: Up to 46 months ] [ Designated as safety issue: Yes ]
  • Bone marrow condition of elderly AML patients [ Time Frame: Up to 46 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 46
Study Start Date: May 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Decitabine, CR rate,OS,EFS,RFS
Therapeutic effect and safety of 10 days of decitabine. Acute myeloid leukemia,no acute promyelocytic leukemia.
 Drug: 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).

Other Name: Dacogen

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633099

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

Additional Information:
We do not have a protocol's home page. This website is our hospital's home page and introduces some information of our hospital.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Jianxiang Wang, deputy director, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01633099     History of Changes
Other Study ID Numbers: DACOGENAML2003
Study First Received: June 24, 2012
Last Updated: July 4, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
decitabine
acute myeloid leukemia
elderly patient

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Decitabine
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013