Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	Other	2004-004414-17 DEPOCYLAN, NCT00388531

Trial Description

Summary

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

Further Study Information

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Program for the Study and Treatment of Hematological Malignancies

Josep Mª Ribera, Doctor

Study Chair

Josep Mª Ribera, doctor		Ph: 661 75 98 70
		Email: jribera@iconcologia.net

Spain
	Barcelona
	Hospital Clinic de Barcelona
		Esteve Jordi, Dr	Principal Investigator
	Hospital de la Santa Cruz i Sant Pau
		Brunet Salut, Dr	Principal Investigator
	Hospital Universitari Germans Trias i Pujol
		Jospe Mª Ribera, Doctor	Ph: 34 93 4978987
			Email: jribera@iconcologia.net
	Madrid
	Hospital Universitario 12 de Octubre
		Juan Jose Lahuerta	Principal Investigator
	Hospital Universitario San Carlos
		Del Potro Eloy, Dr	Principal Investigator
	Málaga
	Hospital Universitario Virgen de la Victoria
		Moreno Mª José, Dr	Principal Investigator
	Salamanca
	University Hospital - Salamanca
		Hernández Rivas Jesús Mª, Dr	Principal Investigator
	Sevilla
	Hospital Universidad Virgen Del Rocio
		Parody Ricardo, Dr	Principal Investigator
	Valencia
	Hospital Universitario La Fe
		Sanz Miguel Angel, Dr	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00388531
Information obtained from ClinicalTrials.gov on March 18, 2009