PROCEDYTE: An Open, Prospective, Multicentre Clinical Trial With Historic Control to Determine Efficacy and Safety of Depocyte® Administration (Liposomal Cytarabine) as Prophylaxis of Neuromeningeal Infiltration of Patients Between 16 and 30 Years Old With Standard Risk Acute Lymphoblastic Leukemia (ALL
A total of 85 patients between 16 and 30 years old with ALL of standard risk will be
included in the study. The aim of this study is to determine the efficacy and safety of the
administration of DepoCyte® as the only IT prophylaxis of the neuromeningeal relapse in
patients between 16 and 30 years old diagnosed with ALL of standard risk.
The study is divided in:
Screening: 2 weeks before treatment Treatment: 2 years of systemic treatment according to
PETHEMA LAL-RI-08 Protocol (Induction, Consolidation 1 and 2, Maintenance-1 with
reinductions and maintenance 2 with no reinductions). Patients will receive DepoCyte® in
Induction, Consolidation 1 and 2 and Maintenance 1 (first year). Patients will not receive
DepoCyte® in Maintenance-2 (second year).
Follow-up: Patients in the study will be followed up for one year
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Efficacy and safety of DepoCyte®, as the only intrathecal (IT) prophylaxis of neuromeningeal relapse
1 year
Yes
Sancho Jose Manuel, Dr
Study Chair
HOSPITAL GERMANS TRIAS I PUJOL
Spain: Ministry of Health
PRODECYTE
NCT00944008
September 2009
December 2013
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