Cytarabine in Combination With Arsenic Trioxide vs. Cytarabine Alone in Elderly Patients With Acute Myeloid Leukemia

Stopped early · Phase 3

Conditions studied: Acute Myeloid Leukemia

In brief

The primary objective of this study is to determine whether low-dose cytarabine in combination with arsenic trioxide is more effective than low-dose cytarabine alone in achieving complete remission in elderly patients (≥60 years of age) with acute myeloid leukemia.

Key facts

Study ID

NCT00513305

Run by

Cephalon

People needed

67

Starts

2007-10-01

Expected to finish

2009-12-01

Last updated by the study team

2012-08-01

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• USC / Norris Cancer Hospital — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• University of Illinois — Chicago, Illinois, United States
• Indiana Oncology Hematology Consultants — Indianapolis, Indiana, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• St. Vincent's Comprehensive Cancer Center — New York, New York, United States
• Weill Medical College of Cornell University — New York, New York, United States
• Brody School of Medicine — Greenville, North Carolina, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• UT Health Science Center — San Antonio, Texas, United States
• Princess Margaret Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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