Prognostic Value of Clinical and Biological Factors in Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma (PRO-R-IPI)

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

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.

Study Overview

• Status: Completed
• Conditions: 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

• Study Type: Observational
• Enrollment (Actual): 158

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with refractory/relapsed diffuse large B-cell lymphoma

Description

• 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
refractory/relapsed LDCBG; patients with refractory/relapsed diffuse large B-cell lymphoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R-IPI Index (Revised International Prognostic Index)	Data will be recorded from diagnosis to second line response, an expected average of 7 months	At diagnoses
R-IPI Index (Revised International Prognostic Index)	The IPI is based on the evaluation of 5 clinical factors: age > 60 years Ann Arbor stage III or IV disease > 1 extra nodal site European Cooperative Oncology Group performance status (ECOG PS) _ 2, increased serum LDH (lactate dehydrogenase) levels Revised IPI (R-IPI) evaluates the same parameters, but groups them differently to form 3 prognostic groups of patients with significantly different progression-free survival and overall survival outcomes.	At the beginning of the 2nd line of treatment, an average of 2 years
Predictive Value of R-IPI at Diagnosis		At diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bcl-2 Expression	immunohistochemical reaction of cells with Bcl-2 antibody	At diagnosis
Bcl-2 Expression	immunohistochemical reaction of cells with Bcl-2 antibody	At the beginning of the 2nd line of treatment
Bcl-6 Expression	immunohistochemical reaction of cells with Bcl-6 antibody	At diagnosis
Bcl-6 Expression	immunohistochemical reaction of cells with Bcl-6 antibody	At the beginning of the second line of treatment
p-53 Expression	immunohistochemical reaction of cells with p-53 antibody	At diagnosis
p53 Expression	immunohistochemical reaction of cells with p-53 antibody	At the beginning of the 2nd line of treatment
Multiple Myeloma Oncogene 1 (MUM-1) Expression	immunohistochemical reaction of cells with MUM-1 antibody	At diagnosis
MUM-1 Expression	immunohistochemical reaction of cells with MUM-1 antibody	At the beginning of the 2nd line of treatment
Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status	ECOG=0: Fully active, able to carry on all pre-disease performance without restriction ECOG=5: Exitus	At the beginning of the 2nd line of treatment
Ann Arbor Staging	Ann Arbor=I: Best condition Ann Arbor=IV: Worst condition	At the beginning of the 2nd line of treatment
Response to First Line of Treatment	Complete Response (CR), Disappearance of all target lesions for at least 8 weeks. Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment.	After first line treatment
Response to Second Line of Treatment	Complete Response (CR), Disappearance of all target lesions for at least 8 weeks. Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment.	After second line of treatment
Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis	Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse	At diagnosis
Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis	Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse	At diagnosis
Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis	Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse	At diagnosis
Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis	Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse	At diagnosis

Collaborators and Investigators

• Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
• Investigators: Study Chair: Carlos Panizo, PhD, Grupo Español de Linfomas/Trasplante Autólogo de Médula Ósea

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: June 8, 2011
• First Posted (Estimate): June 9, 2011

Study Record Updates

• Last Update Posted (Estimate): April 18, 2016
• Last Update Submitted That Met QC Criteria: March 17, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Diffuse large B-cell Lymphoma; R-IPI
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: PRO-R-IPI