Clinical trial · Interventional
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
NCT01633099CI-TRIAL-00007344unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Drug Safety | — | UNRESOLVED | — |
| Effect of Drugs | — | UNRESOLVED | — |
| Untreated Adult Acute Myeloid Leukemia | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decitabine | Drug | Decitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Decitabine, CR rate,OS,EFS,RFS
- description
- Therapeutic effect and safety of 10 days of decitabine. Acute myeloid leukemia,no acute promyelocytic leukemia.
- interventionNames
- Drug: Decitabine
Primary outcomes (4)
- measure
- Complete response rate after induction chemotherapy with decitabine
- timeFrame
- 21 days after the induction chemotherapy
- measure
- Overall survival rate
- timeFrame
- Up to 46 months after inclusion
- measure
- Event free survival rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDBurnett 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