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

NCT ID: NCT00388531

Last Updated: 2011-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2011-06-30

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

Conditions

Lymphoblastic Leukemia; Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Depocyte®

Depocyte® is a cytostatic drug

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PETHEMA Foundation

OTHER

Sponsor Role: lead

Responsible Party

pethema

Principal Investigators

Josep Mª Ribera, Doctor

Role: STUDY_CHAIR

Germans Trias i Pujol Hospital

Locations

Hospital "Santa Creu i Sant Pau"

Barcelona, Barcelona, Spain

Hospital Clínico y Provincial de Barcelona

Barcelona, Barcelona, Spain

Hospital Germans Trias i Pujol

Barcelona, Barcelona, Spain

Hospital Clínico San Carlos de Madrid

Madrid, Madrid, Spain

Hospital Doce de Octubre

Madrid, Madrid, Spain

. Hospital Clínico Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

Hospital La Fe

Valencia, Valencia, Spain

Hospital Clínico Universitario de Salamanca

Salamanca, , Spain

Countries

Spain

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Related Links

http://www.aehh.org

Spanish association of Haematology

http://www.seif88.com

CRO

Other Identifiers

DEPOCYLAN

Identifier Type: -

Identifier Source: secondary_id

2004-004414-17

Identifier Type: -

Identifier Source: org_study_id