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

This study has been completed.
Sponsor:
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00388531
First received: October 16, 2006
Last updated: September 16, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Lymphoblastic Leukemia
Lymphoma
Drug: Depocyte®
Phase 2

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

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • The primary purpose: [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • response rate after one application of DepoCyte®. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: March 2006
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Depocyte®
    Depocyte® is a cytostatic drug
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388531

Locations
Spain
Hospital "Santa Creu i Sant Pau"
Barcelona, Spain
Hospital Germans Trias i Pujol
Barcelona, Spain
Hospital Clínico y Provincial de Barcelona
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
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Study Chair: Josep Mª Ribera, Doctor HOSPITAL GERMANS TRIAS I PUJOL
  More Information

Additional Information:
CRO  This link exits the ClinicalTrials.gov site

Publications:
Elonen E, Almqvist A, Hänninen A et al. Intensive treatment of acute lymphatic leukaemia in adults: ALL86 protocol. Haematologica. 1991;76 (Suppl 4):133
Gökbuget N, Aguion-Freire E, Diedrich H et al. Characteristics and outcome of CNS relapse in patients with acute lymphoblastic leukemia (ALL) [abstract]. Blood. 1999;94:1287a.
Gökbuget N, Arnold R, Eggeling B et al. Prospective evaluation of neurotoxicity of prophylactic intrathecal therapy in adult acute lymphoblastic leukemia. The Hematology Journal. 2000;1:591a.
Howell SB. Liposomal cytarabine for the treatment of lymphomatous meningitis. Biological Therapy of Lymphoma. 2003;6:10-14.
Bomgaars J, Geyer J, Franklin J, et al. A phase I study of intrathecal liposomal cytarabine (DepoCyt) in pediatric patients with advanced meningeal malignancies. Proc Am Soc Clin Oncol. 2002;Abstract 433.

Responsible Party: Pethema, pethema
ClinicalTrials.gov Identifier: NCT00388531     History of Changes
Other Study ID Numbers: 2004-004414-17, DEPOCYLAN
Study First Received: October 16, 2006
Last Updated: September 16, 2011
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by PETHEMA Foundation:
Acute Lymphoblastic Leucemia
Aggressive Non-Hodgkin-Lymphoma
CNS relapse
Cytarabine liposome

Additional relevant MeSH terms:
Aggression
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma
Behavioral Symptoms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014