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Study of Prognostic Factors in Adult Lymphoblastic Lymphoma

Sponsor
PETHEMA Foundation (Other)
Overall Status
Recruiting
CT.gov ID
NCT03571997
Collaborator
(none)
30
Enrollment
28
Locations
54.5
Anticipated Duration (Months)
1.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Retrospective observational study with systematic collection of data on filiation (age at diagnosis and sex), clinical data (IPI, ECOG, early response to chemotherapy, overall response to chemotherapy), biological (strain B or T, infiltration of the nervous system central [CNS], bone marrow [MO], lactate dehydrogenase (LDH) level at the time of diagnosis, as well as genetic patients included in the study, as well as the PETHEMA protocol used in the treatment of same patients The study will review the PETHEMA protocols from 2003 to the present

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Retrospective observational study with systematic collection of data on filiation (age at diagnosis and sex), clinical data (IPI, ECOG, early response to chemotherapy, overall response to chemotherapy), biological (strain B or T, infiltration of the nervous system central [CNS], bone marrow [MO], lactate dehydrogenase (LDH) level at the time of diagnosis, as well as genetic patients included in the study, as well as the PETHEMA protocol used in the treatment of same patients The study will review the PETHEMA protocols from 2003 to the present. Analysis of the main clinical-biological variables as independent risk factors in adult patients (> 15 years) diagnosed with ALL

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    FPLLA-PETHEMA-001: Study of Prognostic Factors in Adult Lymphoblastic Lymphoma
    Actual Study Start Date :
    Jun 15, 2018
    Anticipated Primary Completion Date :
    Dec 30, 2022
    Anticipated Study Completion Date :
    Dec 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Description pronostic factors [1 year]

      Study of the main clinical-biological variables as independent risk factors in adult patients (> 15 years) diagnosed with ALL

    Secondary Outcome Measures

    1. overall survival [1 year]

      To study if there has been an increase in overall survival (OS), in patients diagnosed with ALL in the different PETHEMA protocols

    2. Progression free survival [1 year]

      To study if there has been an increase in progression-free survival (PFS) in patients diagnosed with ALL in the different PETHEMA protocols

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Patients >15 years old diagnosed with ALL and treated with the PETHEMA protocols for ALL

    Exclusion Criteria:

    None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Central de Asturias Oviedo Asturias Spain
    2 Hospital Mútua de Terrassa Terrassa Barcelona Spain
    3 Hospital General de Alicante Alicante Spain
    4 H. de la Santa Creu I Sant Pau Barcelona Spain
    5 H. Vall d'Hebron, Barcelona Barcelona Spain
    6 H.Universitari Germans Trias I Pujol de Badalona Barcelona Spain
    7 Hospital Clínic de Barcelona Barcelona Spain
    8 Hospital de Basurto Basurto Spain
    9 ICO-Duran i Reynals Bellvitge Spain
    10 Hospital Donostia Donostia Spain
    11 H. Univ. de Girona Dr. Josep Trueta (ICO) Girona Spain
    12 Hospital Arnau de Vilanova (Lleida) Lleida Spain
    13 Hospital Lucus Augusti Lugo Spain
    14 H. Gregorio Marañón Madrid Spain
    15 Hospital General Universitario Morales Messeguer Murcia Spain
    16 Hospital San Pedro de Alcántara. Málaga Spain
    17 Hospital Son Espases Palma De Mallorca Spain
    18 Hospital Son Llatzer Palma de Mallorca Spain
    19 Complejo Hospitalario de Navarra Pamplona Spain
    20 Parc Taulí Sabadell Spain
    21 H. Univ. de Salamanca Salamanca Spain
    22 C. H. U. de Santiago Santiago de Compostela Spain
    23 Complejo Hosp. Regional Virgen del Rocío Sevilla Spain 41013
    24 Hospital del Valme Sevilla Spain
    25 H. Joan XXIII Tarragona Spain
    26 Hoapital La Fe Valencia Spain
    27 Hospital Arnau de Vilanova (Valencia) Valencia Spain
    28 Hospital Universitari Clínic València Valencia Spain

    Sponsors and Collaborators

    • PETHEMA Foundation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    PETHEMA Foundation
    ClinicalTrials.gov Identifier:
    NCT03571997
    Other Study ID Numbers:
    • FPLLA-PETHEMA-001
    First Posted:
    Jun 28, 2018
    Last Update Posted:
    Feb 1, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Lymphoma, Non-Hodgkin

    Study Results

    No Results Posted as of Feb 1, 2022