Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia

Inclusion Criteria

• Diagnosis of refractory or relapsed ALL (acute lymphocytic leukemia)
• Age greater than or equal to 15 years
• No chemotherapy, radiation, or major surgery within 2 weeks prior to first dose of study drug and recovered from toxic side effects of that therapy, unless treatment is indicated due to progressive disease.
• No investigational therapy within 4 weeks of first dose of study drug
• ECOG performance status (PS) 0 to 2.
• Adequate liver function
• Adequate renal function
• Signed informed consent

Exclusion Criteria

• Concommitant therapy that includes other chemotherapy that is or may be active against ALL (except central nervous system [CNS] therapy)
• Any condition which in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study.
• Cardiac ejection fraction less than 40%
• Clinically relevant serious co-morbid medical conditions.
• Pregnant, lactating or not using adequate contraception.
• Known allergy to doxorubicin or anthracyclines.