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

NCT01593488 | Unknown Phase 2

• 2 other identifiers: CILI2011-002622-48
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 10

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.

Conditions

Acute Lymphoblastic Leukemia

Keywords

recurrent; CNS disease; intrathecal therapy

Outcome Measures

Primary Outcomes (2)

• number of cerebrospinal fluid (CSF) responses

  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

  assessed from date of patient registration to date of cerebrospinal fluid response, up to 12 weeks

Secondary Outcomes (8)

• time to reaching CSF response

  date of patient registration to date of CSF response, up to 12 weeks

• duration of CSF response

  up to 12 months

• worst grade non neurologic Adverse event during induction, according to CTCAE 4.02

  up to 12 weeks

• worst grade toxicity after induction therapy according to CTCAE 4.02

  up to 12 months

• overall survival

  one year

Study Arms (1)

Intrathecal liposomal cytarabine

EXPERIMENTAL

Drug: liposomal cytarabine

Interventions

liposomal cytarabine DRUG

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)

Intrathecal liposomal cytarabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Naples: lead
• Santobono-Pausilpon Hospital: collaborator
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator
• University of Bologna: collaborator

Study Sites (10)

P.O. Gaspare Rodolico

Catania, Italy

Location

Istituto G. Gasilini

Genova, Italy

Location

Ospedale S. Gerardo Clinica Pediatrica

Monza, Italy

Location

AORN Santobon - Pauslipon

Napoli, Italy

Location

A.O. Università Padova

Padua, Italy

Location

ARNAS Osp Civico di Cristina

Palermo, Italy

Location

IRCCS Ospedale Bambino Gesu'

Roma, Italy

Location

Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Location

IRCCS Burlo Garofalo Istituto per l'Infanzia Emato Oncologia

Trieste, Italy

Location

Ospedale Policlinico G.B. Rossi

Verona, Italy

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Recurrence; Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 8, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

IT (10)