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

NCT00388531 | Completed Phase 2

• 2 other identifiers: 2004-004414-17DEPOCYLAN
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Lymphoblastic Leukemia; Lymphoma

Keywords

Acute Lymphoblastic Leucemia; Aggressive Non-Hodgkin-Lymphoma; CNS relapse; Cytarabine liposome

Outcome Measures

Primary Outcomes (2)

• The primary purpose:

  1 year

• response rate after one application of DepoCyte®.

  1 year

Secondary Outcomes (1)

• 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

Interventions

Depocyte® DRUG

Depocyte® is a cytostatic drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute lymphoblastic leukemia or very aggressive Non-Hodgkin-Lymphoma (Burkitt/Burkitt-like) and CNS relapse.
• CNS involvement must be demonstrated by:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PETHEMA Foundation: lead

Study Sites (9)

Hospital "Santa Creu i Sant Pau"

Barcelona, Barcelona, Spain

Location

Hospital Clínico y Provincial de Barcelona

Barcelona, Barcelona, Spain

Location

Hospital Germans Trias i Pujol

Barcelona, Barcelona, Spain

Location

Hospital Clínico San Carlos de Madrid

Madrid, Madrid, Spain

Location

Hospital Doce de Octubre

Madrid, Madrid, Spain

Location

. Hospital Clínico Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

Location

Hospital La Fe

Valencia, Valencia, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, Spain

Location

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Related Links

• Spanish association of Haematology
• CRO

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Josep Mª Ribera, Doctor

  Germans Trias i Pujol Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 16, 2006
• First Posted: October 17, 2006
• Study Start: March 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 19, 2011

Record last verified: 2011-09

Locations

ES (9)