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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01593488
Recruitment Status : Active, not recruiting
First Posted : May 8, 2012
Last Update Posted : March 5, 2021
Santobono-Pausilpon Hospital
IRCCS Azienda Ospedaliero-Universitaria di Bologna
University of Bologna
Information provided by (Responsible Party):
National Cancer Institute, Naples

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: liposomal cytarabine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2012
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

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)

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. worst grade non neurologic Adverse event during induction, according to CTCAE 4.02 [ Time Frame: up to 12 weeks ]
  4. worst grade toxicity after induction therapy according to CTCAE 4.02 [ Time Frame: up to 12 months ]
    Measured from date of CSF response

  5. overall survival [ Time Frame: one year ]
  6. time from patient registration to progression of disease in non CNS site [ Time Frame: up to one year ]
  7. 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 ]
  8. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01593488

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P.O. Gaspare Rodolico
Catania, Italy
Istituto G. Gasilini
Genova, Italy
Ospedale S. Gerardo Clinica Pediatrica
Monza, Italy
AORN Santobon - Pauslipon
Napoli, Italy
A.O. Università Padova
Padova, Italy
ARNAS Osp Civico di Cristina
Palermo, Italy
IRCCS Ospedale Bambino Gesu'
Roma, Italy
Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
IRCCS Burlo Garofalo Istituto per l'Infanzia Emato Oncologia
Trieste, Italy
Ospedale Policlinico G.B. Rossi
Verona, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Santobono-Pausilpon Hospital
IRCCS Azienda Ospedaliero-Universitaria di Bologna
University of Bologna
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Principal Investigator: Rosanna Parasole, M.D. Santobono - Pausilipon Hospital
Principal Investigator: Massimo Di Maio, M.D. National Cancer Institute, Naples
Principal Investigator: Francesco Perrone, M.D., Ph.D. National Cancer Institute, Naples
Principal Investigator: A. Pession Policlinico S. Orsola-Malpighi, Bologna
Principal Investigator: William Morello Policlinico S. Orsola-Malpighi, Bologna
Principal Investigator: E. Strocchi University of Bologna
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Responsible Party: National Cancer Institute, Naples Identifier: NCT01593488    
Other Study ID Numbers: CILI
2011-002622-48 ( EudraCT Number )
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021
Keywords provided by National Cancer Institute, Naples:
CNS disease
intrathecal therapy
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs