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

Primary Purpose

Acute Lymphoblastic Leukemia

Status

Active

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

liposomal cytarabine

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring recurrent, CNS disease, intrathecal therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intrathecal liposomal cytarabine

Arm Description

Outcomes

Primary Outcome Measures

number of cerebrospinal fluid (CSF) responses

number of patients with grade 3 or higher neurological adverse events, excluding headache) according to CTCAE 4.02

Secondary Outcome Measures

time to reaching CSF response

date of reaching CSF response is the first date of two consecutive negative cytomorphologic exams of CSF

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

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

worst grade toxicity after induction therapy according to CTCAE 4.02

Measured from date of CSF response

overall survival

time from patient registration to progression of disease in non CNS site

concentration of study drug present in CSF at each induction therapy

correlation of activity and toxicity with residual study drug level in CSF during induction

Full Information

NCT ID

NCT01593488

First Posted

April 27, 2012

Last Updated

March 23, 2023

Sponsor

National Cancer Institute, Naples

Collaborators

Santobono-Pausilpon Hospital, IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Bologna

1. Study Identification

Unique Protocol Identification Number

NCT01593488

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 2012 (undefined)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute, Naples

Collaborators

Santobono-Pausilpon Hospital, IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Bologna

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Lymphoblastic Leukemia

Keywords

recurrent, CNS disease, intrathecal therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intrathecal liposomal cytarabine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

liposomal cytarabine

Intervention Description

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)

Primary Outcome Measure Information:

Title

number of cerebrospinal fluid (CSF) responses

Time Frame

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

Title

number of patients with grade 3 or higher neurological adverse events, excluding headache) according to CTCAE 4.02

Time Frame

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

Secondary Outcome Measure Information:

Title

time to reaching CSF response

Description

date of reaching CSF response is the first date of two consecutive negative cytomorphologic exams of CSF

Time Frame

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

Title

duration of CSF response

Description

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

Time Frame

up to 12 months

Title

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

Time Frame

up to 12 weeks

Title

worst grade toxicity after induction therapy according to CTCAE 4.02

Description

Measured from date of CSF response

Time Frame

up to 12 months

Title

overall survival

Time Frame

one year

Title

time from patient registration to progression of disease in non CNS site

Time Frame

up to one year

Title

concentration of study drug present in CSF at each induction therapy

Time Frame

prior to each induction therapy at 15 day intervals for up to 6 cycles

Title

correlation of activity and toxicity with residual study drug level in CSF during induction

Time Frame

measured at 15 day intervals for up to 6 cycles

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: