Intravenous (IV) Decitabine and Oral Bexarotene for Acute Myelogenous Leukemia (AML)

Completed · Phase 1

Conditions studied: Leukemia, Myeloid, Acute

In brief

The main objective is to determine the safety and tolerability of combination decitabine and bexarotene during four cycles of therapy.

Key facts

Study ID

NCT01001143

Run by

Washington University School of Medicine

People needed

19

Starts

2010-05-01

Expected to finish

2014-05-01

Last updated by the study team

2014-07-29

Who can join

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

You may qualify if…

• AML with bone marrow blasts ≥ 20%.
• Relapsed disease after 1 or more lines of prior salvage chemotherapy and any FAB-AML, or
• Diagnosis of AML and age ≥ 60 and not a candidate for cytotoxic chemotherapy and any FAB-AML except FAB-M3.
• Performance status ≤ 2.
• Age ≥ 18 years.

You may not qualify if…

• Peripheral white blood cell count (WBC) > 10,000/microliter.
• Total bilirubin > 1.5 x normal.
• AST/ALT > 2.5 x normal.
• Serum creatinine > 2 x normal.
• Fasting serum triglyceride > 1,000 mg/dL.
• Active or poorly controlled graft vs host disease (GVHD).
• Pregnant or nursing.
• Known CNS leukemia.
• History of positive HIV serology.
• History of positive Hepatitis C serology.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congestive heart failure of NYHA class 3 or 4, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
• Chemotherapy within 21 days of enrollment.
• Radiation therapy within 14 days of enrollment.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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