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

NCT01633099 | Unknown Phase 3 DMC

• 1 other identifier: DACOGENAML2003
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Untreated Adult Acute Myeloid Leukemia; Effect of Drugs; Drug Safety

Keywords

decitabine; acute myeloid leukemia; elderly patient

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• 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

Study Arms (1)

Decitabine, CR rate,OS,EFS,RFS

OTHER

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

Drug: Decitabine

Interventions

Decitabine 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).

Also known as: Dacogen

Decitabine, CR rate,OS,EFS,RFS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of acute myeloid leukemia.De novo or secondary AML.
• Age \>= 60years,female and male.
• Before the enrollment，WBC \< 40×10E9/L，Plt \> 20×10E9/L（Hydroxyurea is permitted.）
• 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）.
• 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.
• Contraception must be taken to avoid pregnancy during the study.
• ECOG 0,1, or 2, predicted lifetime longer than 12 weeks.
• Patients must sign the informed consent prior to any study related screening procedures being performed.

You may not qualify if:

• Acute promyelocytic leukemia.
• Chromosome and genetic abnormalities related with t（8; 21）、inv（16）、t（15; 17）.
• Central nervous system leukemia.
• Bone marrow dry tap.
• 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.
• Patients suffered from autoimmune hemolytic anemia or immune thrombocytopenia.
• Patients suffered from non-leukemia related comorbidities that will cause dysfunction of organs.
• Patients suffered from unstable angina or （NYHA）3/4 Congestive heart failure.
• Patients suffered from chronic respiratory disease and needed continued oxygen.
• Other active malignancy.
• Active HBV,HCV or AIDS patients.
• Uncontrolled virus or bacterium infection.
• The investigator believe that patients who are not suitable for this trial.
• Severe mental or body disorders which will interfere the research such as uncontrolled heart,lung diseases,diabetes,etc.
• Allergic to decitabine or its accessory.

Sponsors & Collaborators

• Jianxiang Wang: lead
• Xian-Janssen Pharmaceutical Ltd.: collaborator

Related Publications (1)

• 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.

  PMID: 17315155 BACKGROUND

Related 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.

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Jianxiang Wang, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: deputy director

Study Record Dates

• First Submitted: June 24, 2012
• First Posted: July 4, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2016
• Last Updated: July 6, 2012

Record last verified: 2012-07