Liposomal Cytarabine in the Treatment of Central Nervous System Resistant or Relapsed Acute Lymphoblastic Leukemia in Children
NCT ID: NCT01593488
Last Updated: 2023-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
31 participants
INTERVENTIONAL
2012-03-31
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intrathecal liposomal cytarabine
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Santobono-Pausilpon Hospital
UNKNOWN
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
University of Bologna
OTHER
National Cancer Institute, Naples
OTHER
Responsible Party
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Principal Investigators
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Rosanna Parasole, M.D.
Role: PRINCIPAL_INVESTIGATOR
Santobono-Pausilipon Hospital
Massimo Di Maio, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Francesco Perrone, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
A. Pession
Role: PRINCIPAL_INVESTIGATOR
Policlinico S. Orsola-Malpighi, Bologna
William Morello
Role: PRINCIPAL_INVESTIGATOR
Policlinico S. Orsola-Malpighi, Bologna
E. Strocchi
Role: PRINCIPAL_INVESTIGATOR
University of Bologna
Locations
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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
Padua, , 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
Countries
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Other Identifiers
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2011-002622-48
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CILI
Identifier Type: -
Identifier Source: org_study_id
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