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

Phase 2

Active, not recruiting

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Drug: liposomal cytarabine

• Registration Number: NCT01593488
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-27
• Study First Submitted QC: 2012-05-04
• Study First Posted: 2012-05-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intrathecal liposomal cytarabine	liposomal cytarabine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
duration of CSF response	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
worst grade non neurologic Adverse event during induction, according to CTCAE 4.02	up to 12 weeks
time to reaching CSF response	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
worst grade toxicity after induction therapy according to CTCAE 4.02	up to 12 months	Measured from date of CSF response
overall survival	one year
correlation of activity and toxicity with residual study drug level in CSF during induction	measured at 15 day intervals for up to 6 cycles

Trial Locations

Locations (10)

Istituto G. Gasilini; 🇮🇹 Genova, Italy

ARNAS Osp Civico di Cristina; 🇮🇹 Palermo, Italy

Casa Sollievo della Sofferenza; 🇮🇹 San Giovanni Rotondo, Italy

P.O. Gaspare Rodolico; 🇮🇹 Catania, Italy

AORN Santobon - Pauslipon; 🇮🇹 Napoli, Italy

Ospedale S. Gerardo Clinica Pediatrica; 🇮🇹 Monza, Italy

A.O. Università Padova; 🇮🇹 Padova, Italy

IRCCS Ospedale Bambino Gesu'; 🇮🇹 Roma, Italy

Ospedale Policlinico G.B. Rossi; 🇮🇹 Verona, Italy

IRCCS Burlo Garofalo Istituto per l'Infanzia Emato Oncologia; 🇮🇹 Trieste, Italy