Therapeutic Effect and Safety Study of Decitabine in Elderly Acute Myeloid Leukemia Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01633099 |
Recruitment Status : Unknown
Verified July 2012 by Jianxiang Wang, Chinese Academy of Medical Sciences.
Recruitment status was: Active, not recruiting
First Posted : July 4, 2012
Last Update Posted : July 6, 2012
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Untreated Adult Acute Myeloid Leukemia Effect of Drugs Drug Safety | Drug: Decitabine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 46 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | May 2012 |
Estimated Primary Completion Date : | July 2014 |
Estimated Study Completion Date : | July 2016 |

Arm | Intervention/treatment |
---|---|
Decitabine, CR rate,OS,EFS,RFS
Therapeutic effect and safety of 10 days of decitabine. Acute myeloid leukemia,no acute promyelocytic leukemia.
|
Drug: 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 |
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Patients received other researches in last 30 days.
- Without contraception.
- Complications causing organ dysfunction which are not caused by AML.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633099
Principal Investigator: | Jianxiang Wang, MD | Institute of Hematology, Hospital of Blood Disease, Chinese Academy of Medical Sciences |
Publications:
Responsible Party: | Jianxiang Wang, deputy director, Chinese Academy of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT01633099 |
Other Study ID Numbers: |
DACOGENAML2003 |
First Posted: | July 4, 2012 Key Record Dates |
Last Update Posted: | July 6, 2012 |
Last Verified: | July 2012 |
decitabine acute myeloid leukemia elderly patient |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms Decitabine |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors |