NCT03571997

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

28 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

4.5 years

First QC Date

June 18, 2018

Last Update Submit

January 31, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • overall survival

    1 year

  • Progression free survival

    1 year

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Hospital Mútua de Terrassa

Terrassa, Barcelona, Spain

RECRUITING

Hospital Central de Asturias

Oviedo, Principality of Asturias, Spain

RECRUITING

Hospital General de Alicante

Alicante, Spain

RECRUITING

H. de la Santa Creu I Sant Pau

Barcelona, Spain

RECRUITING

H. Vall d'Hebron, Barcelona

Barcelona, Spain

RECRUITING

H.Universitari Germans Trias I Pujol de Badalona

Barcelona, Spain

RECRUITING

Hospital Clínic de Barcelona

Barcelona, Spain

RECRUITING

Hospital de Basurto

Basurto, Spain

RECRUITING

ICO-Duran i Reynals

Bellvitge, Spain

RECRUITING

Hospital Donostia

Donostia / San Sebastian, Spain

RECRUITING

H. Univ. de Girona Dr. Josep Trueta (ICO)

Girona, Spain

RECRUITING

Hospital Arnau de Vilanova (Lleida)

Lleida, Spain

RECRUITING

Hospital Lucus Augusti

Lugo, Spain

RECRUITING

H. Gregorio Marañón

Madrid, Spain

RECRUITING

Hospital San Pedro de Alcántara.

Málaga, Spain

RECRUITING

Hospital General Universitario Morales Messeguer

Murcia, Spain

RECRUITING

Hospital Son Espases

Palma de Mallorca, Spain

RECRUITING

Hospital Son Llatzer

Palma de Mallorca, Spain

RECRUITING

Complejo Hospitalario de Navarra

Pamplona, Spain

RECRUITING

Parc Taulí

Sabadell, Spain

RECRUITING

H. Univ. de Salamanca

Salamanca, Spain

RECRUITING

C. H. U. de Santiago

Santiago de Compostela, Spain

RECRUITING

Complejo Hosp. Regional Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Hospital del Valme

Seville, Spain

RECRUITING

H. Joan XXIII

Tarragona, Spain

RECRUITING

Hoapital La Fe

Valencia, Spain

RECRUITING

Hospital Arnau de Vilanova (Valencia)

Valencia, Spain

RECRUITING

Hospital Universitari Clínic València

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Miguel Sagüés Serrano, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2018

First Posted

June 28, 2018

Study Start

June 15, 2018

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

February 1, 2022

Record last verified: 2022-01

Locations