Status:
COMPLETED
Intravenous (IV) Decitabine and Oral Bexarotene for Acute Myelogenous Leukemia (AML)
Lead Sponsor:
Washington University School of Medicine
Conditions:
Leukemia, Myeloid, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The main objective is to determine the safety and tolerability of combination decitabine and bexarotene during four cycles of therapy.
Detailed Description
The investigators are seeking to study the combination of decitabine and bexarotene. These two agents have each shown efficacy in decreasing leukemic blast counts and restoring normal hematopoiesis vi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01001143
Start Date
May 1 2010
End Date
May 1 2014
Last Update
July 29 2014
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110