Spots Global Cancer Trial Database for Decitabine in Combination With Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia

Study Description

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

Keywords

Eligibility

Minimum Age: 60 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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