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

Phase I/II Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia

This is a Phase I/II multi-center, open label, dose escalation study to identify the maximum tolerated dose (MTD) of liposomal annamycin and to evaluate the safety of liposomal annamycin in patients with refractory or relapsed acute lymphocytic leukemia.

This is a Phase I/II, multi-center, open-label, dose escalation, MTD study of liposomal annamycin in refractory or relapsed ALL patients. Enrollment will occur in cohorts of approximately 3 patients with 10 additional patients enrolled at the MTD. The liposomal annamycin doses will be escalated in sequential cohorts. Four dose levels of liposomal annamycin are planned: 190, 230, 280, and 310 mg/m2/day.

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.