Clinical trial · Interventional
Liposomal Cytarabine in the Treatment of Central Nervous System Resistant or Relapsed Acute Lymphoblastic Leukemia in Children
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| liposomal cytarabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intrathecal liposomal cytarabine
- interventionNames
- Drug: liposomal cytarabine
Primary outcomes (2)
- measure
- number of cerebrospinal fluid (CSF) responses
- timeFrame
- 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
- measure
- number of patients with grade 3 or higher neurological adverse events, excluding headache) according to CTCAE 4.02
- timeFrame
- assessed from date of patient registration to date of cerebrospinal fluid response, up to 12 weeks
Secondary outcomes (8)
- measure
- time to reaching CSF response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available