| Exclusion Criteria: | 1) Extramedullary leukemia
2) Patients on a vitamin A preparation or patients with hypervitaminosis A
3) Have received cytotoxic therapy </= 2 weeks from the start of therapy. If the patient needs these agents due to urgent medical care within 2 weeks prior to starting tamibarotene, a waiver may be granted by the CytRx Medical Monitor
4) Have a history of myelodysplastic syndromes (MDS)
5) Have impaired cardiac function or clinically significant heart disease including: myocardial infarction within 3 months, unstable angina pectoris, congenital long QT syndrome and clinically significant resting bradycardia (<50 beats per minute), uncontrolled congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with antihypertensive medication
6) Have an active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment
7) Have clinically significant acute or chronic liver or renal disease considered unrelated to leukemia
8) Have uncontrolled hyperlipidemia
9) Have uncontrolled or poorly controlled diabetes mellitus
10) Have impaired gastrointestinal function that may significantly alter drug absorption (e.g., uncontrolled vomiting, ulcerative colitis, malabsorption, or small bowel resection)
11) Are pregnant or lactating
12) Have psychiatric disorder(s) that would interfere with consent, study participation, or follow-up
13) Have not recovered from acute toxicities of all previous therapy prior to enrollment to at least grade 1
14) Have any other severe concurrent disease and/or uncontrolled medical conditions, which, in the judgment of the investigator, could predispose patients to unacceptable safety risks or compromise compliance with the protocol
15) Have a history of another primary malignancy that has been actively treated in the last 24 months
16) Are unwilling or unable to comply with the protocol |