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
60 Years
N/A
Both
Acute Myeloid Leukemia
Trial Information
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
Inclusion Criteria:
- The patient has confirmed acute myeloid leukemia (AML).
- The patient is unwilling or unable to tolerate conventional induction chemotherapy.
- The patient has no comorbid conditions that would limit life expectancy to less than
3 months.
- Patient must meet specific laboratory parameters for study inclusion.
Exclusion Criteria:
- The patient has had previous cytotoxic chemotherapy for acute myeloid leukemia (AML) or
myelodysplastic syndrome (MDS).
Previous treatment with low-dose cytarabine is not permitted.
- The patient has a QT interval outside of the protocol-specified range.
- The patient has laboratory values outside of protocol-specified ranges.
- The patient is concurrently treated with cytotoxic therapy, radiation, or
investigational agents.
- The patient has uncontrolled, severe cardiovascular or pulmonary disease or other
uncontrolled medical condition.
- The patient has known central nervous system involvement with AML.
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
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| Weill Medical College of Cornell University | New York, New York 10021 |
| University of Oklahoma | Oklahoma City, Oklahoma 73190 |
| St. Vincent's Comprehensive Cancer Center | New York, New York 10011 |
| UCLA Medical Center | Los Angeles, California 90095-7059 |
| Indiana Oncology Hematology Consultants | Indianapolis, Indiana 46202 |
| Brody School of Medicine | Greenville, North Carolina 27858 |
| University of Illinois | Chicago, Illinois 60612 |
| UT Health Science Center | San Antonio, Texas 78245-3217 |
| USC / Norris Cancer Hospital | Los Angeles, California 90033 |
