Multicentered Phase II Study Evaluating the Activity and Toxicity of Liposomal Cytarabine in the Treatment of Children and Adolescents With Acute Lymphoblastic Leukemia With Resistent or Relapsed Central Nervous System Involvement
Liposomal cytarabine (DepoCyte) is a new formulation of the drug cytarabine, a drug commonly
used in the treatment of ALL. This formulation of the drug can be given intrathecally (into
the spinal fluid), and is released slowly over a longer period, about two weeks. This
allows a longer exposure of the drug to the central nervous system, and requires fewer
intrathecal injections for the patient.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
number of cerebrospinal fluid (CSF) responses
from two weeks after date of patient registration until the date of second consecutive cerebrospinal fluid exam that is negative for malignant cells, up to 12 weeks
Rosanna Parasole, M.D.
Santobono - Pausilipon Hospital
Italy: Ethics Committee