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

NCT01593488 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-03-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

liposomal cytarabine

given intrathecally in induction phase every 15 days until CSF response for up to 7 injections. Then it is given every 4 weeks during consolidation phase while patient awaiting bone marrow transplant. For those patients who are not candidates for a bone marrow transplant, the drug will be given every 3 months for 4 administrations (maintenance therapy)

Sponsors & Collaborators

  • Santobono-Pausilpon Hospital

    collaborator UNKNOWN

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    collaborator OTHER

  • University of Bologna

    collaborator OTHER

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Rosanna Parasole, M.D. · Santobono-Pausilipon Hospital

  • Massimo Di Maio, M.D. · National Cancer Institute, Naples

  • Francesco Perrone, M.D., Ph.D. · National Cancer Institute, Naples

  • A. Pession · Policlinico S. Orsola-Malpighi, Bologna

  • William Morello · Policlinico S. Orsola-Malpighi, Bologna

  • E. Strocchi · University of Bologna

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01593488 on ClinicalTrials.gov