Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia
- 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
- 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.
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.
Trial Phase Phase I/II
Trial Type Treatment
- Primary ID CP-103
- Secondary IDs NCI-2010-02297
- Clinicaltrials.gov ID NCT00271063