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

• Status: Terminated
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cephalon
• Treatments: Arsenic Trioxide; Cytarabine

Criteria

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.