A Phase I Dose Escalation Study of Intravenous Decitabine in Combination With Oral Bexarotene in Patients With Acute Myeloid Leukemia (AML)
18 Years
N/A
Both
Leukemia, Myeloid, Acute
Trial Information
A Phase I Dose Escalation Study of Intravenous Decitabine in Combination With Oral Bexarotene in Patients With Acute Myeloid Leukemia (AML)
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 via different mechanisms of action and with non-overlapping side-effect
profiles. By combining these agents, the investigators hope to improve overall response
rates. The investigators further hope to improve platelet and neutrophil counts in an even
greater number of patients, thus treating two of the most important sources of morbidity and
mortality in this patient population.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Toxicity of combination decitabine and bexarotene during four cycles of therapy
Outcome Time Frame:
After 4 cycles of therapy
Safety Issue:
Yes
Principal Investigator
Amanda Cashen, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Washington University School of Medicine
Authority:
United States: Institutional Review Board
Study ID:
09-1661 / 201012801
NCT ID:
NCT01001143
Start Date:
March 2010
Completion Date:
March 2015
Related Keywords:
- Leukemia, Myeloid, Acute
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|---|
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
