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

Phase 2

Completed

• Conditions: Lymphoblastic Leukemia; Lymphoma

• Registration Number: NCT00388531
• Lead Sponsor: PETHEMA Foundation

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

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-10-16
• Study First Submitted QC: 2006-10-16
• Study First Posted: 2006-10-17
• Primary Completion: 2011-03
• Study Completion: 2011-06
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-16
• Last Update Posted: 2011-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The primary purpose:	1 year
response rate after one application of DepoCyte®.	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

Hospital Clínico Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Doce de Octubre; 🇪🇸 Madrid, Spain

Hospital "Santa Creu i Sant Pau"; 🇪🇸 Barcelona, Spain

Hospital Clínico y Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Clínico San Carlos de Madrid; 🇪🇸 Madrid, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Barcelona, Spain

. Hospital Clínico Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain