Clinical trial NCT01369784: Prognostic Value of Clinical and Biological Factors in Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B-cell Lymphoma
Keywords: Diffuse large B-cell Lymphoma
R-IPI
Lead sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Sponsor class: OTHER
First posted: 2011-06-09
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with refractory/relapsed diffuse large B-cell lymphoma

Brief 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.

Detailed 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

Eligibility criteria: * 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

Primary outcomes:
measure: R-IPI Index (Revised International Prognostic Index)
timeFrame: At diagnoses
measure: R-IPI Index (Revised International Prognostic Index)
timeFrame: At the beginning of the 2nd line of treatment, an average of 2 years
measure: Predictive Value of R-IPI at Diagnosis
timeFrame: At diagnosis
Secondary outcomes:
measure: Bcl-2 Expression
timeFrame: At diagnosis
measure: Bcl-2 Expression
timeFrame: At the beginning of the 2nd line of treatment
measure: Bcl-6 Expression
timeFrame: At diagnosis
measure: Bcl-6 Expression
timeFrame: At the beginning of the second line of treatment
measure: p-53 Expression
timeFrame: At diagnosis
measure: p53 Expression
timeFrame: At the beginning of the 2nd line of treatment
measure: Multiple Myeloma Oncogene 1 (MUM-1) Expression
timeFrame: At diagnosis
measure: MUM-1 Expression
timeFrame: At the beginning of the 2nd line of treatment
measure: Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status
timeFrame: At the beginning of the 2nd line of treatment
measure: Ann Arbor Staging
timeFrame: At the beginning of the 2nd line of treatment
measure: Response to First Line of Treatment
timeFrame: After first line treatment
measure: Response to Second Line of Treatment
timeFrame: After second line of treatment
measure: Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis
timeFrame: At diagnosis
measure: Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis
timeFrame: At diagnosis
measure: Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis
timeFrame: At diagnosis
measure: Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis
timeFrame: At diagnosis
Other outcomes:
Locations:
city: Elda
country: Spain
facility: Hospital de Elda
state: Alicante
city: Gijón
country: Spain
facility: Hospital de Cabueñes
state: Asturias
city: Oviedo
country: Spain
facility: H. U. Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: H. U. Germans Trias i Pujol
state: Barcelona
city: Granollers
country: Spain
facility: Hospital General de Granollers
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: ICO-DYR
state: Barcelona
city: Manresa
country: Spain
facility: Althaia
state: Barcelona
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
state: Barcelona
city: Torrelavega
country: Spain
facility: H. Sierrallana
state: Cantabria
city: Jerez de la Frontera
country: Spain
facility: Hospital General del SAS de Jerez
state: Cádiz
city: San Sebastián
country: Spain
facility: Hospital Galdakao
state: Guipuzcoa
city: Santiago de Compostela
country: Spain
facility: H. Clínico U. Santiago de Compostela
state: La Coruña
city: Logroño
country: Spain
facility: Hospital San Pedro
state: La Rioja
city: Alcorcón
country: Spain
facility: H.U. Fundación Alcorcón
state: Madrid
city: Getafe
country: Spain
facility: H.U.de Getafe
state: Madrid
city: Leganés
country: Spain
facility: H. Severo Ochoa
state: Madrid
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
state: Navarra
city: Pamplona
country: Spain
facility: Hospital de Navarra
state: Navarra
city: La Laguna
country: Spain
facility: H. Universitario de Canarias
state: Tenerife
city: Talavera de la Reina
country: Spain
facility: H. Nuestra Señora del Prado
state: Toledo
city: Bilbao
country: Spain
facility: H. Basurto
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall D'Hebrón
city: Gerona
country: Spain
facility: Institut Catalá d'Oncologia de Girona
city: Granada
country: Spain
facility: H.U. Virgen de las Nieves
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: La Coruña
country: Spain
facility: C.H.U. A Coruña
city: León
country: Spain
facility: Hospital de León
city: Lugo
country: Spain
facility: Hospital Xeral
city: Lérida
country: Spain
facility: Hospital Universitario Arnau de Vilanova
city: Madrid
country: Spain
facility: H. Ramón y Cajal
city: Madrid
country: Spain
facility: H. U. La Princesa
city: Madrid
country: Spain
facility: H.G.U. Gregorio Marañón
city: Madrid
country: Spain
facility: H.U. La Paz
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: MD Anderson
city: Mallorca
country: Spain
facility: Hospital Son Llatzer
city: Murcia
country: Spain
facility: H.U. Virgen de la Arrixaca
city: Murcia
country: Spain
facility: Hospital Morales Messeguer
city: Málaga
country: Spain
facility: H. Carlos Haya
city: Orense
country: Spain
facility: Complexo Hospitalario de Ourense
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Dureta
city: Salamanca
country: Spain
facility: H. Universitario de Salamanca
city: Segovia
country: Spain
facility: H. General de Segovia
city: Sevilla
country: Spain
facility: H.U. Nuestra Señora de Valme
city: Valencia
country: Spain
facility: H. Arnau de Vilanova
city: Valencia
country: Spain
facility: H. Clínico de Valencia
city: Valencia
country: Spain
facility: H. Dr. Peset
city: Valladolid
country: Spain
facility: H. Río Hortega
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario Valladolid
city: Zamora
country: Spain
facility: H. Virgen de La Concha
city: Ávila
country: Spain
facility: H. Nuestra Señora de Sonsoles
city: Vitoria
country: Spain
facility: H. Txagorritxu
state: Álava
Study officials:
affiliation: Grupo Español de Linfomas/Trasplante Autólogo de Médula Ósea
name: Carlos Panizo, PhD
role: STUDY_CHAIR
References: