Clinical trial NCT00388531: Depocyte in the Treatment of CNS Relapse in Patients With Lymphoblastic Leucemia or Very Aggressive Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoblastic Leukemia
Lymphoma
Keywords: Acute Lymphoblastic Leucemia
Aggressive Non-Hodgkin-Lymphoma
CNS relapse
Cytarabine liposome
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2006-10-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The first purpose is to confirm or not the efficacy of only one administration of DepoCyte®.

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

Eligibility criteria: 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

Primary outcomes:
measure: The primary purpose:
timeFrame: 1 year
measure: response rate after one application of DepoCyte®.
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital "Santa Creu i Sant Pau"
city: Barcelona
country: Spain
facility: Hospital Clínico y Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos de Madrid
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Málaga
country: Spain
facility: . Hospital Clínico Universitario Virgen de la Victoria
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
affiliation: Germans Trias i Pujol Hospital
name: Josep Mª Ribera, Doctor
role: STUDY_CHAIR
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