Spots Global Cancer Trial Database for Liposomal Cytarabine in the Treatment of Central Nervous System Resistant or Relapsed Acute Lymphoblastic Leukemia in Children

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Trial Identification

Brief Title: Liposomal Cytarabine in the Treatment of Central Nervous System Resistant or Relapsed Acute Lymphoblastic Leukemia in Children

Official Title: 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

Study ID: NCT01593488

Conditions

Acute Lymphoblastic Leukemia

Interventions

liposomal cytarabine

Study Description

Brief Summary: The purpose of this study is to describe the activity and toxicity of a new formulation of cytarabine called liposomal cytarabine given into the central nervous system for the treatment of central nervous system localization of acute lymphoblastic leukemia (ALL) in children and adolescents.

Detailed Description: 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.

Keywords

recurrent

CNS disease

intrathecal therapy

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

P.O. Gaspare Rodolico, Catania, , Italy

Istituto G. Gasilini, Genova, , Italy

Ospedale S. Gerardo Clinica Pediatrica, Monza, , Italy

AORN Santobon - Pauslipon, Napoli, , Italy

A.O. Università Padova, Padova, , Italy

ARNAS Osp Civico di Cristina, Palermo, , Italy

IRCCS Ospedale Bambino Gesu', Roma, , Italy

Casa Sollievo della Sofferenza, San Giovanni Rotondo, , Italy

IRCCS Burlo Garofalo Istituto per l'Infanzia Emato Oncologia, Trieste, , Italy

Ospedale Policlinico G.B. Rossi, Verona, , Italy