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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03571997
Other study ID # FPLLA-PETHEMA-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 15, 2018
Est. completion date December 30, 2022

Study information

Verified date January 2022
Source PETHEMA Foundation
Contact Miguel Sagüés Serrano, Dr
Phone 972 225 158
Email msagues@iconcologia.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria: Patients >15 years old diagnosed with ALL and treated with the PETHEMA protocols for ALL Exclusion Criteria: None

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Hospital General de Alicante Alicante
Spain H. de la Santa Creu I Sant Pau Barcelona
Spain H. Vall d'Hebron, Barcelona Barcelona
Spain H.Universitari Germans Trias I Pujol de Badalona Barcelona
Spain Hospital Clínic de Barcelona Barcelona
Spain Hospital de Basurto Basurto
Spain ICO-Duran i Reynals Bellvitge
Spain Hospital Donostia Donostia
Spain H. Univ. de Girona Dr. Josep Trueta (ICO) Girona
Spain Hospital Arnau de Vilanova (Lleida) Lleida
Spain Hospital Lucus Augusti Lugo
Spain H. Gregorio Marañón Madrid
Spain Hospital San Pedro de Alcántara. Málaga
Spain Hospital General Universitario Morales Messeguer Murcia
Spain Hospital Central de Asturias Oviedo Asturias
Spain Hospital Son Espases Palma De Mallorca
Spain Hospital Son Llatzer Palma de Mallorca
Spain Complejo Hospitalario de Navarra Pamplona
Spain Parc Taulí Sabadell
Spain H. Univ. de Salamanca Salamanca
Spain C. H. U. de Santiago Santiago de Compostela
Spain Complejo Hosp. Regional Virgen del Rocío Sevilla
Spain Hospital del Valme Sevilla
Spain H. Joan XXIII Tarragona
Spain Hospital Mútua de Terrassa Terrassa Barcelona
Spain Hoapital La Fe Valencia
Spain Hospital Arnau de Vilanova (Valencia) Valencia
Spain Hospital Universitari Clínic València Valencia

Sponsors (1)

Lead Sponsor Collaborator
PETHEMA Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Description pronostic factors Study of the main clinical-biological variables as independent risk factors in adult patients (> 15 years) diagnosed with ALL 1 year
Secondary overall survival To study if there has been an increase in overall survival (OS), in patients diagnosed with ALL in the different PETHEMA protocols 1 year
Secondary Progression free survival 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
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