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NCT01369784 Clinical Trial

Prognostic Value of Clinical and Biological Factors in Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma

Diffuse Large B-cell Lymphoma Clinical Trial

— PRO-R-IPI  

Official title:
Observational, Post-authorization, Cross-sectional Study to Evaluate the Prognostic Value of Clinical and Biological Factors in Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01369784
Other study ID # PRO-R-IPI
Secondary ID
Status Completed
Phase N/A
First received February 23, 2011
Last updated June 8, 2011
Start date February 2009
Est. completion date March 2011

Study information
Verified date June 2011
Source Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the prognostic value of clinical and biological factors in patients with refractory/relapsed Diffuse Large B-Cell Lymphoma.

Description:

The main aim of this study is to compare the prognostic value of R-IPI at diagnosis and relapse, relating it with the obtained response after second line

Recruitment information / eligibility
Status Completed
Enrollment 158
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility - Age 18 > years old

- Patients with refractory/relapsed diffuse large B-cell lymphoma after first line treatment with rituximab, with or without transplantation. Patients must have finished a rescue treatment including rituximab

- Ability to understand and willingness to sign a written informed consent

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Spain H.U. Fundación Alcorcón Alcorcón Madrid
Spain H. Nuestra Señora de Sonsoles Ávila
Spain H. U. Germans Trias i Pujol Badalona Barcelona
Spain Hospital Clinic i Provincial Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital Vall D'Hebrón Barcelona
Spain H. Basurto Bilbao Vizcaya
Spain Hospital de Elda Elda Alicante
Spain Institut Catalá d'Oncologia de Girona Gerona
Spain H.U.de Getafe Getafe Madrid
Spain Hospital de Cabueñes Gijón Asturias
Spain H.U. Virgen de las Nieves Granada
Spain Hospital General de Granollers Granollers Barcelona
Spain ICO-DYR Hospitalet de Llobregat Barcelona
Spain Complejo Hospitalario de Jaén Jaén
Spain Hospital General del SAS de Jerez Jerez de la Frontera Cádiz
Spain C.H.U. A Coruña La Coruña
Spain H. Universitario de Canarias La Laguna Tenerife
Spain H. Severo Ochoa Leganés Madrid
Spain Hospital de León León
Spain Hospital Universitario Arnau de Vilanova Lérida
Spain Hospital San Pedro Logroño La Rioja
Spain Hospital Xeral Lugo
Spain H. Ramón y Cajal Madrid
Spain H. U. La Princesa Madrid
Spain H.G.U. Gregorio Marañón Madrid
Spain H.U. La Paz Madrid
Spain Hospital 12 de Octubre Madrid
Spain MD Anderson Madrid
Spain H. Carlos Haya Málaga
Spain Hospital Son Llatzer Mallorca
Spain Althaia Manresa Barcelona
Spain Hospital Costa del Sol Marbella Málaga
Spain Hospital de Mataró Mataró Barcelona
Spain H.U. Virgen de la Arrixaca Murcia
Spain Hospital Morales Messeguer Murcia
Spain Complexo Hospitalario de Ourense Orense
Spain H. U. Central de Asturias Oviedo Asturias
Spain Hospital Universitario Son Dureta Palma de Mallorca
Spain Clínica Universitaria de Navarra Pamplona Navarra
Spain Hospital de Navarra Pamplona Navarra
Spain Hospital Parc Taulí Sabadell Barcelona
Spain H. Universitario de Salamanca Salamanca
Spain Hospital Galdakao San Sebastián Guipuzcoa
Spain H. Clínico U. Santiago de Compostela Santiago de Compostela La Coruña
Spain H. General de Segovia Segovia
Spain H.U. Nuestra Señora de Valme Sevilla
Spain H. Nuestra Señora del Prado Talavera de la Reina Toledo
Spain H. Sierrallana Torrelavega Cantabria
Spain H. Arnau de Vilanova Valencia
Spain H. Clínico de Valencia Valencia
Spain H. Dr. Peset Valencia
Spain H. Río Hortega Valladolid
Spain Hospital Clínico Universitario Valladolid Valladolid
Spain H. Txagorritxu Vitoria Álava
Spain H. Virgen de La Concha Zamora

Sponsors (1)
Lead Sponsor Collaborator
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary R-IPI Index Data will be recorded from diagnosis to second line response, an expected average of 7 months Average of 7 months No
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