Depocyte in the Treatment of CNS Relapse in Patients With Lymphoblastic Leucemia or Very Aggressive Lymphoma

Study Overview
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Brief Summary
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The first purpose is to confirm or not the efficacy of only one administration of DepoCyte®.

Detailed Description
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It is a clinical study multicenter, prospective, open label trial, uncontrolled and nonrandomized

Official Title
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Multicenter, Prospective, Open Label Trial, Uncontrolled to Determine the Efficacy and Safety of Depocyt ® for the Treatment of CNS Relapse in Adult Patients With Lymphoblastic Leucemia or Very Aggressive Lymphoma

Conditions
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Lymphoblastic Leukemia, Lymphoma

Intervention / Treatment
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* Drug: Depocyte®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute lymphoblastic leukemia or very aggressive Non-Hodgkin-Lymphoma (Burkitt/Burkitt-like) and CNS relapse. CNS involvement must be demonstrated by: A positive ventricular or lumbar CSF cytology defined as CSF cell counts > 5/µl (19/3 cells), obtained within 10 days prior to inclusion OR Characteristic signs and symptoms of neoplastic meningitis PLUS an MRI or CT scan indicating the presence of meningeal involvement. Patients with combined relapse in CNS and other locations may be included in case that systemic therapy with CNS active drugs (HDMTX;HDAC, Thiotepa) can be postponed for at least 2 weeks. Karnofsky >60% Age >18 years old Recovery from grade III/IV toxicities attributable to prior treatment with the exception of hematotoxicity. No severe heart, lung, liver or kidney dysfunction. The patient or guardian must be competent to provide informed consent and must provide written informed consent prior to the initiation of study procedures Exclusion Criteria: Failure (as defined by no clearance of the CSF) to > 1 dose of prior intrathecal MTX or cytarabine or triple (MTX, ARAC, dexamethasone) therapy History of previous severe neurotoxicity (grade III-IV) attributed to intrathecal therapy or systemic high-dose therapy with methotrexate or cytarabine (vincristine induced peripheral neuropathy is accepted) Prior CNS relapse < 1 month before uncontrolled infection The patient must not be pregnant or breast feeding. If the patient is a female of child-bearing potential she must have a negative (urine or serum) pregnancy test and be using effective methods to prevent pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Depocyte®|Depocyte® is a cytostatic drug|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary purpose: |  | 1 year | 
| response rate after one application of DepoCyte®. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death in induction and in CR, Time to neurological progression, The frequency of improvement in pre-existing meningeal-disease related neurological symptoms,Karnofsky Performance Status,Survival,Toxicity according to CTCAE v.3 |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Lymphoblastic Leucemia, Aggressive Non-Hodgkin-Lymphoma, CNS relapse, Cytarabine liposome