An Open-Label, Randomized Study of Low-Dose Cytarabine in Combination With Arsenic Trioxide Compared With Low-Dose Cytarabine Alone for the Treatment of Elderly Patients With Acute Myeloid Leukemia

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants in Complete Remission (CR)

Outcome Description:

The primary efficacy variable was the percentage of subjects in each treatment group who achieved complete remission after treatment with study drug. Complete remission was defined as: 1) Less than 5% blasts in normocellular bone marrow sample. 2) No blasts in bone marrow sample containing Auer rods. 3)Clearance of previous extramedullary disease. 4)Normal values for absolute neutrophil count (at least 1000/microliter), platelet count (at least 100,000/microliter), without platelet transfusions, and in absence of peripheral myeloblasts.

Outcome Time Frame:

From baseline through Day 70. Assessments were performed on Day 21 in cycle 1, no later than Day 56 of cycle 1 or 2 (if applicable), and no later than Day 70 of cycle 1 or 2 (if applicable) or at any other time at the discretion of the investigator

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

C18477/3059/AM/US-CA

NCT ID:

NCT00513305

Start Date:

October 2007

Completion Date:

December 2009

Related Keywords:

• Acute Myeloid Leukemia
• acute myeloid leukemia, cytarabine, arsenic trioxide.
• Leukemia
• Leukemia, Myeloid, Acute
• Leukemia, Myeloid