NCT02985372

Decitabine in Combination With Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia

Efficacy and Safety of Decitabine in Combination With Low-dose Cytarabine as Inductive Treatment in Newly Diagnosed Elderly Patients With Acute Myeloid Leukemia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chunyan Ji · Academic / Other
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Myeloid Leukemia, Adult

Interventions

Type	Name	Description
DRUG	Decitabine	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).
DRUG	Cytarabine

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2016-12-07
• Last updated: 2016-12-07