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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002622-48 | EudraCT Number |
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| Name | Class |
|---|---|
| Santobono-Pausilpon Hospital | UNKNOWN |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | OTHER |
| University of Bologna | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrathecal liposomal cytarabine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| time to reaching CSF response | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P.O. Gaspare Rodolico | Catania | Italy | ||||
| Istituto G. Gasilini |
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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 | up to 12 weeks |
| worst grade toxicity after induction therapy according to CTCAE 4.02 | Measured from date of CSF response | up to 12 months |
| overall survival | one year |
| time from patient registration to progression of disease in non CNS site | up to one year |
| concentration of study drug present in CSF at each induction therapy | 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 | measured at 15 day intervals for up to 6 cycles |
| Genova |
| Italy |
| Ospedale S. Gerardo Clinica Pediatrica | Monza | Italy |
| AORN Santobon - Pauslipon | Naples | 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 |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D012008 | Recurrence |
| D002493 | Central Nervous System Diseases |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009422 | Nervous System Diseases |
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