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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


Phase 3
60 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia

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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 InstituteBuffalo, New York  14263
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Weill Medical College of Cornell UniversityNew York, New York  10021
University of OklahomaOklahoma City, Oklahoma  73190
St. Vincent's Comprehensive Cancer CenterNew York, New York  10011
UCLA Medical CenterLos Angeles, California  90095-7059
Indiana Oncology Hematology ConsultantsIndianapolis, Indiana  46202
Brody School of MedicineGreenville, North Carolina  27858
University of IllinoisChicago, Illinois  60612
UT Health Science CenterSan Antonio, Texas  78245-3217
USC / Norris Cancer HospitalLos Angeles, California  90033