Treatment of Acute Lymphoblastic Leukemia or Aggressive Lymphoma With Relapse in Central Nervous System With Depocyt

Study Overview
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Brief Summary
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Patients with acute lymphoblastic leukaemia or very aggressive lymphoma and documented isolated CNS relapse or CNS relapse combined with other relapse sites should receive therapy with intrathecal DepoCyte at least once. Treatment may be repeated during induction phase each 2 weeks and monthly during maintenance phase. The study aim is to replace the usual 2-3 weekly applications of intrathecal triple therapy with one application of DepoCyte. Primary objective is the response rate after one application of DepoCyte. Further objectives are the compilation of data regarding safety and toxicity

Official Title
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A Phase-2 Clinical Study to Determine the Efficacy and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of CNS Relapse in Adult Patients With Acute Lymphoblastic Leukemia or Very Aggressive Lymphoma

Conditions
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Adult Acute Lymphocytic Leukemia

Intervention / Treatment
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* Drug: Depocyt
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: proven diagnosis of ALL or very aggressive Non-Hodgkin-Lymphoma (Burkitt/Burkitt-like) and CNS relapse CNS involvement demonstrated by a positive ventricular or lumbar CSF cytology or characteristic signs and symptoms of neoplastic meningitis plus an MRI or CT scan indicating the presence of meningeal involvement in combined relapse in CNS and other locations: systemic therapy with CNS active drugs can be postponed for at least 2 weeks Karnofsky Performance Score is > or = 60% 18 years of age or older free of uncontrolled infection recovered from any grade III / IV toxicities attributable to prior treatment with the exception of hematotoxicity patient not pregnant or breast feeding and effective methods to prevent pregnancy free from severe heart, lung, liver or kidney dysfunction written informed consent Exclusion Criteria: failed to respond (as defined by no clearance of the CSF) to > 1 dose of prior i.th. MTX or ARAC or triple therapy history of neurotoxicity (grade III - IV) attributed to i.th. or systemic HD therapy with MTX or ARAC prior CNS relapse < 1 month before

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Only 1 arm<br> | Drug: Depocyt<br> <br> Drug: Dexamethasone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate after one application of DepoCyte |  | one cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate at later time-points, toxicity (WHO), death in induction and CR, time to neurological progression, frequency of improvement in pre-existing meningeal-disease related neurological symptoms, Karnofsky Performance Status, Survival |  | after each cycle and during follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CNS relapse, ALL, Treatment