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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Azacitidine; Bexarotene; Decitabine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.