Acute Lymphoblastic LeukemiaPhase 2CILINCT01593488
Liposomal Cytarabine in the Treatment of Central Nervous System Resistant or Relapsed Acute Lymphoblastic Leukemia in Children
A Phase 2 study testing liposomal cytarabine in people with Acute Lymphoblastic Leukemia, run by National Cancer Institute, Naples at 10 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- liposomal cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 10 sitesItaly
- Study dates
- Mar 2012to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Life expectancy of at least 8 weeks
- Absence of severe organ dysfunction
- Informed consent
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites
P.O. Gaspare Rodolico
Catania
Istituto G. Gasilini
Genova
Ospedale S. Gerardo Clinica Pediatrica
Monza
AORN Santobon - Pauslipon
Naples
A.O. Università Padova
Padova
ARNAS Osp Civico di Cristina
Palermo
IRCCS Ospedale Bambino Gesu'
Roma
Casa Sollievo della Sofferenza
San Giovanni Rotondo
IRCCS Burlo Garofalo Istituto per l'Infanzia Emato Oncologia
Trieste
Ospedale Policlinico G.B. Rossi
Verona
About this study
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
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.
Read the 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.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- liposomal cytarabine
- Keywords
- recurrent, CNS disease, intrathecal therapy
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal cytarabineDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal liposomal cytarabine | Experimental | Not described Receives: Drug: liposomal cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of cerebrospinal fluid (CSF) responses
Measured: 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
Measured: assessed from date of patient registration to date of cerebrospinal fluid response, up to 12 weeks
Secondary outcomes (8)
time to reaching CSF response
date of reaching CSF response is the first date of two consecutive negative cytomorphologic exams of CSF
Measured: date of patient registration to date of CSF response, up to 12 weeks
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
Measured: up to 12 months
worst grade non neurologic Adverse event during induction, according to CTCAE 4.02
Measured: up to 12 weeks
worst grade toxicity after induction therapy according to CTCAE 4.02
Measured from date of CSF response
Measured: up to 12 months
overall survival
Measured: one year
time from patient registration to progression of disease in non CNS site
Measured: up to one year
concentration of study drug present in CSF at each induction therapy
Measured: 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: measured at 15 day intervals for up to 6 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Collaborators
- Santobono-Pausilpon Hospital, IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Bologna
- Responsible party
- Sponsor
- Investigators
- Rosanna Parasole, M.D., Principal investigator, Santobono-Pausilipon HospitalMassimo Di Maio, M.D., Principal investigator, National Cancer Institute, NaplesFrancesco Perrone, M.D., Ph.D., Principal investigator, National Cancer Institute, NaplesA. Pession, Principal investigator, Policlinico S. Orsola-Malpighi, BolognaWilliam Morello, Principal investigator, Policlinico S. Orsola-Malpighi, BolognaE. Strocchi, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593488
- Sponsor's protocol ID
- CILI
- Other IDs
- 2011-002622-48
- Acronym
- CILI
- Status last verified
- Mar 2023
- First submitted
- 27 Apr 2012
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01593488
- Acronym / sponsor ID
- CILI / CILI
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- recurrent, CNS disease, intrathecal therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Collaborators
- Santobono-Pausilpon Hospital, IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Bologna
- Study start
- Mar 2012
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intrathecal liposomal cytarabine | Experimental | Drug: liposomal cytarabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liposomal cytarabinegiven 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) | Drug | Intrathecal liposomal cytarabine |
Primary outcome
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
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
8 secondary outcomes
time to reaching CSF response
Time frame: date of patient registration to date of CSF response, up to 12 weeks
duration of CSF response
Time frame: up to 12 months
worst grade non neurologic Adverse event during induction, according to CTCAE 4.02
Time frame: up to 12 weeks
worst grade toxicity after induction therapy according to CTCAE 4.02
Time frame: up to 12 months
overall survival
Time frame: one year
time from patient registration to progression of disease in non CNS site
Time frame: up to one year
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosanna Parasole, M.D. principal investigator
Santobono-Pausilipon Hospital
Massimo Di Maio, M.D. principal investigator
National Cancer Institute, Naples
Francesco Perrone, M.D., Ph.D. principal investigator
National Cancer Institute, Naples
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing liposomal cytarabine in people with Acute Lymphoblastic Leukemia, run by National Cancer Institute, Naples at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.