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

Information source: PETHEMA Foundation
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoblastic Leukemia; Lymphoma

Intervention: Depocyte® (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: PETHEMA Foundation

Official(s) and/or principal investigator(s):
Josep Mª Ribera, Doctor, Study Chair, Affiliation: Germans Trias i Pujol Hospital

Summary

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

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

The primary purpose:

response rate after one application of DepoCyte®.

Secondary outcome: 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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Hospital "Santa Creu i Sant Pau", Barcelona, Spain

Hospital Clínico y Provincial de Barcelona, Barcelona, Spain

Hospital Germans Trias i Pujol, Barcelona, Spain

Hospital Clínico San Carlos de Madrid, Madrid, Spain

Hospital Doce de Octubre, Madrid, Spain

. Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain

Hospital Clínico Universitario de Salamanca, Salamanca, Spain

Hospital Universitario Virgen del Rocío, Sevilla, Spain

Hospital La Fe, Valencia, Spain

Additional Information

Spanish association of Haematology

CRO

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Starting date: March 2006
Last updated: September 16, 2011

Page last updated: August 20, 2015

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