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

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Collaborators: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi; IRCCS Azienda Ospedaliero-Universitaria di Bologna; Santobono-Pausilpon Hospital; University of Bologna
• Treatments: Cytarabine

Criteria

Inclusion Criteria:

• Age < 18 years

• Diagnosis of acute lymphoblastic leukemia (ALL)

• Central nervous system involvement with malignant cells present in cerebrospinal fluid

• CNS involvement may be refractive to prior systemic therapy, a first recurrence after prior systemic and intrathecal therapy or a second recurrence

• CNS involvement may be an isolated lesion or present with other sites of disease

• ECOG performance status 0-2

• Life expectancy of at least 8 weeks

• Absence of severe organ dysfunction

• Informed consent

Exclusion Criteria:

• Eligibility for AIEOP studies of first recurrence of ALL,and receiving therapy in a center participating in the AIEOP studies

• Concurrent treatment with experimental therapies

• Severe neurologic toxicities from previous chemotherapy

• Severe coagulopathy at time of recurrence

• Sepsis

• Intrathecal therapy within 1 week of planned study therapy

• Total body or head and spine radiation within 8 weeks of enrolment

• Bone marrow transplant within 8 weeks of start of study therapy.