Arsenic Trioxide in Combination With Cytarabine in Patients With High-risk MDS and Poor-prognosis AML

Completed · Phase 1/Phase 2

Conditions studied: Myelodysplastic Syndrome

In brief

The purpose of this study is to find out the effectiveness and side effects of arsenic trioxide in combination with low-dose ara-C.

Key facts

Study ID

NCT00195104

Run by

Weill Medical College of Cornell University

People needed

87

Starts

2003-09-17

Expected to finish

2006-06-20

Last updated by the study team

2017-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic diagnosis of high-risk MDS (IPSS int-2).
• No prior cytotoxic therapy for MDS or AML (patients may have received prior therapy with hematopoietic growth factors, immunomodulatory agents or 5-azacitidine).

You may not qualify if…

• Pregnant or lactating women.
• Absolute QT interval >460 msec in the presence of serum potassium and magnesium values within the normal range.
• Concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents.
• Uncontrolled or severe cardiovascular or pulmonary disease.

Where it is running

• Weill Medcial College of Cornell University — New York, New York, United States

Full record on ClinicalTrials.gov

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