Study of Prognostic Factors in Adult Lymphoblastic Lymphoma

January 31, 2022 updated by: PETHEMA Foundation

FPLLA-PETHEMA-001: Study of Prognostic Factors in Adult Lymphoblastic Lymphoma

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Alicante, Spain
        • Recruiting
        • Hospital General de Alicante
        • Contact:
          • Cristina Gil
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic De Barcelona
        • Contact:
          • Jordi Esteve
      • Barcelona, Spain
        • Recruiting
        • H. de La Santa Creu I Sant Pau
        • Contact:
          • Irene García Cadenas
      • Barcelona, Spain
        • Recruiting
        • H. Vall d'Hebron, Barcelona
        • Contact:
          • Pere Barba
      • Barcelona, Spain
        • Recruiting
        • H.Universitari Germans Trias I Pujol de Badalona
        • Contact:
          • Josep Maria Ribera
      • Basurto, Spain
        • Recruiting
        • Hospital de Basurto
        • Contact:
          • Cristina Barrenetxea Lekue
      • Bellvitge, Spain
        • Recruiting
        • ICO-Duran i Reynals
        • Contact:
          • Santiago Mercadal
      • Donostia, Spain
        • Recruiting
        • Hospital Donostia
        • Contact:
          • Teresa Artola
      • Girona, Spain
        • Recruiting
        • H. Univ. de Girona Dr. Josep Trueta (ICO)
        • Contact:
          • Rosa Coll
      • Lleida, Spain
        • Recruiting
        • Hospital Arnau de Vilanova (Lleida)
        • Contact:
          • Antoni Garcia-Guiñon
      • Lugo, Spain
        • Recruiting
        • Hospital Lucus Augusti
        • Contact:
          • María José Sánchez Sánchez
      • Madrid, Spain
        • Recruiting
        • H. Gregorio Marañón
        • Contact:
          • Silvia Monsalvo
      • Murcia, Spain
        • Recruiting
        • Hospital General Universitario Morales Messeguer
        • Contact:
          • Maria Luz Amigo
      • Málaga, Spain
        • Recruiting
        • Hospital San Pedro de Alcántara.
        • Contact:
          • Bergua Juan, Dr
      • Palma De Mallorca, Spain
        • Recruiting
        • Hospital Son Espases
        • Contact:
          • Andrés Novo
      • Palma de Mallorca, Spain
        • Recruiting
        • Hospital Son Llatzer
        • Contact:
          • Antònia Cladera
      • Pamplona, Spain
        • Recruiting
        • Complejo Hospitalario de Navarra
        • Contact:
          • Maria Carmen Mateos Rodríguez
      • Sabadell, Spain
        • Recruiting
        • PARC Tauli
        • Contact:
          • Sonia Piernas
      • Salamanca, Spain
        • Recruiting
        • H. Univ. de Salamanca
        • Contact:
          • Jesús Maria Hernández Rivas
      • Santiago de Compostela, Spain
        • Recruiting
        • C. H. U. de Santiago
        • Contact:
          • Natalia Alonso, Dr
      • Sevilla, Spain, 41013
        • Recruiting
        • Complejo Hosp. Regional Virgen del Rocío
        • Contact:
          • José González Campos, Dr
      • Sevilla, Spain
        • Recruiting
        • Hospital del Valme
        • Contact:
          • Maria Ángeles Domínguez
      • Tarragona, Spain
        • Recruiting
        • H. Joan XXIII
        • Contact:
          • Marta Cervera
      • Valencia, Spain
        • Recruiting
        • Hoapital La Fe
        • Contact:
          • Pau Montesinos
      • Valencia, Spain
        • Recruiting
        • Hospital Arnau de Vilanova (Valencia)
        • Contact:
          • Aurelio López
      • Valencia, Spain
        • Recruiting
        • Hospital Universitari Clínic València
        • Contact:
          • Mar Tormo
    • Asturias
      • Oviedo, Asturias, Spain
        • Recruiting
        • Hospital Central de Asturias
        • Contact:
          • Teresa Bernal
    • Barcelona
      • Terrassa, Barcelona, Spain
        • Recruiting
        • Hospital Mútua de Terrassa
        • Contact:
          • Ferran Vall-Llovera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description pronostic factors
Time Frame: 1 year
Study of the main clinical-biological variables as independent risk factors in adult patients (> 15 years) diagnosed with ALL
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 1 year
To study if there has been an increase in overall survival (OS), in patients diagnosed with ALL in the different PETHEMA protocols
1 year
Progression free survival
Time Frame: 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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2018

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

June 18, 2018

First Submitted That Met QC Criteria

June 18, 2018

First Posted (Actual)

June 28, 2018

Study Record Updates

Last Update Posted (Actual)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPLLA-PETHEMA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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