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, 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the safety and tolerability of L-Annamycin
8 months
Yes
Gary Jacob, PhD
Study Director
Callisto Pharmaceuticals
United States: Food and Drug Administration
CP-103
NCT00271063
October 2005
April 2008
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Montefiore Medical Center | Bronx, New York 10467-2490 |