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

March 23, 2023 updated by: National Cancer Institute, Naples

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catania, Italy
        • P.O. Gaspare Rodolico
      • Genova, Italy
        • Istituto G. Gasilini
      • Monza, Italy
        • Ospedale S. Gerardo Clinica Pediatrica
      • Napoli, Italy
        • AORN Santobon - Pauslipon
      • Padova, Italy
        • A.O. Università Padova
      • Palermo, Italy
        • ARNAS Osp Civico di Cristina
      • Roma, Italy
        • IRCCS Ospedale Bambino Gesu'
      • San Giovanni Rotondo, Italy
        • Casa Sollievo Della Sofferenza
      • Trieste, Italy
        • IRCCS Burlo Garofalo Istituto per l'Infanzia Emato Oncologia
      • Verona, Italy
        • Ospedale Policlinico G.B. Rossi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intrathecal liposomal cytarabine
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of cerebrospinal fluid (CSF) responses
Time Frame: 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
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
number of patients with grade 3 or higher neurological adverse events, excluding headache) according to CTCAE 4.02
Time Frame: assessed from date of patient registration to date of cerebrospinal fluid response, up to 12 weeks
assessed from date of patient registration to date of cerebrospinal fluid response, up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: one year
one year
time to reaching CSF response
Time Frame: date of patient registration to date of CSF response, up to 12 weeks
date of reaching CSF response is the first date of two consecutive negative cytomorphologic exams of CSF
date of patient registration to date of CSF response, up to 12 weeks
duration of CSF response
Time Frame: up to 12 months
duration of response is the length of time in days from the date of the CSF response to the date of the first positive cytomorphologic CSF exam
up to 12 months
worst grade non neurologic Adverse event during induction, according to CTCAE 4.02
Time Frame: up to 12 weeks
up to 12 weeks
worst grade toxicity after induction therapy according to CTCAE 4.02
Time Frame: up to 12 months
Measured from date of CSF response
up to 12 months
time from patient registration to progression of disease in non CNS site
Time Frame: up to one year
up to one year
concentration of study drug present in CSF at each induction therapy
Time Frame: prior to each induction therapy at 15 day intervals for up to 6 cycles
prior to each induction therapy at 15 day intervals for up to 6 cycles
correlation of activity and toxicity with residual study drug level in CSF during induction
Time Frame: measured at 15 day intervals for up to 6 cycles
measured at 15 day intervals for up to 6 cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna
University of Bologna
Santobono-Pausilpon Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

April 27, 2012

First Submitted That Met QC Criteria

May 4, 2012

First Posted (Estimate)

May 8, 2012

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CILI
  • 2011-002622-48 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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