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

Acute Lymphoblastic Leukemia Clinical Trial

— CILI  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01593488
• Other study ID #: CILI
• Secondary ID: 2011-002622-48
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2012
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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)

Locations

Country	Name	City	State
Italy	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

Sponsors (4)

Lead Sponsor	Collaborator
National Cancer Institute, Naples	IRCCS Azienda Ospedaliero-Universitaria di Bologna, Santobono-Pausilpon Hospital, University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	duration of CSF response	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
Secondary	worst grade non neurologic Adverse event during induction, according to CTCAE 4.02		up to 12 weeks
Secondary	worst grade toxicity after induction therapy according to CTCAE 4.02	Measured from date of CSF response	up to 12 months
Secondary	overall survival		one year
Secondary	time from patient registration to progression of disease in non CNS site		up to one year
Secondary	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
Secondary	correlation of activity and toxicity with residual study drug level in CSF during induction		measured at 15 day intervals for up to 6 cycles