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

Acute Myeloid Leukemia, Adult Clinical Trial

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

Status Enrolling by invitation

Clinical Trial 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).

Clinical Trial 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 ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia, Adult
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

• NCT number: NCT02985372
• Study type: Interventional
• Source: Shandong University
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: December 2016
• Completion date: December 2019