Acute Myeloid Leukemia, Adult
Conditions
Brief summary
This prospective multicenter clinical study was designed to assess the efficacy and safety of decitabine in combination with low-dose cytarabine induction treatment for elderly patients with newly diagnosed acute myeloid leukemia (AML).
Detailed description
All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13). Hydroxyurea was permitted as rescue medication if white blood count (WBC) was \>20×109/L and but was discontinued at least 24h before decitabine treatment. Supportive care including blood product transfusions, G-CSF, antiemetic medications, antiviral and antifungal medications, or empiric antibiotics may be used at the clinical discretion of the investigator. Curative effect was evaluated after two cycles: 1. \<5% blast in the marrow, enter into maintenance therapy (Group A) 2. ≥5% blast in the marrow, continue induction therapy two cycles, ① \<5% blast in the marrow, enter into maintenance therapy (Group B); ② ≥5% blast in the marrow, dropped out of the study (Group C) 3. marrow blast decline \<60%, dropped out of the study (Group C). Maintenance therapy regimen: 1. Ara-C 1g/m2/d iv drip d1-4 1 cycle 2. DEC 15mg/m2/d iv drip d1-5 1 cycle 3. Ara-C 1g/m2/d iv drip d1-4 1 cycle 4. DEC 15mg/m2/d iv drip d1-5 1 cycle
Interventions
DRUGDecitabine
All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13).
DRUGCytarabine
Sponsors
Binzhou Medical University
Shengli Oilfield Hospital
Heze Municipal Hospital
Jinan Military Genaral Hospital
Jinan Central Hospital
Jining Medical University
Linyi People's Hospital
Qingdao University
Rizhao People's Hospital
Qianfoshan Hospital
Qilu Hospital of Shandong University (Qingdao)
Taian City Central Hospital
Taishan Medical University Affiliated Hospital
Weihai Municipal Hospital
Weifang Medical University
Zibo First Hospital
Central Hospital of Zibo
Chunyan Ji
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with previously untreated non-M3 AML (diagnosed by the WHO2016 criteria). 2. Age: ≥ 60 and ≤ 75 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5x upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine \< 2ULN. 5. Without central nervous system symptoms. 6. Willing to accept the follow-up. 7. Normal heart function(EF\>50%). The subjects volunteer to sign the informed consent.
Exclusion criteria
1. With severe cardiac, renal or hepatic insufficiency. 2. With other cancers requiring treatment. 3. With other hematological diseases(e.g. Hemophilia, myelofibrosis, etc.). 4. With severe infection or metabolic disease(including tuberculosis and pulmonary aspergillosis). 5. Brain disorders or severe mental diseases which could limit compliance with study requirements. 6. Major operation within 3 weeks. 7. With HIV infection or AIDS-associated diseases. 8. Any drug abuse, medical, mental or social situations which would affect the results. 9. Hypersensitivity to cytarabine (not including drug fever or exanthema) or decitabine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | three years |
| complete remission rate | three years |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | three years |
| progression-free survival | three years |
| mortality rate | three years |
| recurrence rate | three years |
Outcome results
None listed