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

Completed

• Conditions: Diffuse Large B-cell Lymphoma

• Registration Number: NCT01369784
• Lead Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

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

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2011-02-23
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-09
• Results First Submitted: 2014-07-21
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-17
• Last Update Submitted: 2016-03-17
• Results First Posted: 2016-04-18
• Last Update Posted: 2016-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive Value of R-IPI at Diagnosis	At diagnosis
R-IPI Index (Revised International Prognostic Index)	At the beginning of the 2nd line of treatment, an average of 2 years	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.

Secondary Outcome Measures

Name	Time	Method
p-53 Expression	At diagnosis	immunohistochemical reaction of cells with p-53 antibody
p53 Expression	At the beginning of the 2nd line of treatment	immunohistochemical reaction of cells with p-53 antibody
Multiple Myeloma Oncogene 1 (MUM-1) Expression	At diagnosis	immunohistochemical reaction of cells with MUM-1 antibody
Bcl-2 Expression	At the beginning of the 2nd line of treatment	immunohistochemical reaction of cells with Bcl-2 antibody
Bcl-6 Expression	At the beginning of the second line of treatment	immunohistochemical reaction of cells with Bcl-6 antibody
MUM-1 Expression	At the beginning of the 2nd line of treatment	immunohistochemical reaction of cells with MUM-1 antibody
Ann Arbor Staging	At the beginning of the 2nd line of treatment	Ann Arbor=I: Best condition Ann Arbor=IV: Worst condition
Response to First Line of Treatment	After first line 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.
Response to Second Line of Treatment	After 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.
Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis	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
Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis	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
Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis	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
Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status	At the beginning of the 2nd line of treatment	ECOG=0: Fully active, able to carry on all pre-disease performance without restriction ECOG=5: Exitus
Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis	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

Trial Locations

Locations (56)

Hospital de Elda; 🇪🇸 Elda, Alicante, Spain

H. U. Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

H. U. Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital General de Granollers; 🇪🇸 Granollers, Barcelona, Spain

ICO-DYR; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Althaia; 🇪🇸 Manresa, Barcelona, Spain

Hospital Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Hospital de Mataró; 🇪🇸 Mataró, Barcelona, Spain

H. Sierrallana; 🇪🇸 Torrelavega, Cantabria, Spain

Hospital Galdakao; 🇪🇸 San Sebastián, Guipuzcoa, Spain

Hospital San Pedro; 🇪🇸 Logroño, La Rioja, Spain

H. Clínico U. Santiago de Compostela; 🇪🇸 Santiago de Compostela, La Coruña, Spain

H.U. Fundación Alcorcón; 🇪🇸 Alcorcón, Madrid, Spain

H.U.de Getafe; 🇪🇸 Getafe, Madrid, Spain

H. Severo Ochoa; 🇪🇸 Leganés, Madrid, Spain

Clínica Universitaria de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital de Navarra; 🇪🇸 Pamplona, Navarra, Spain

H. Universitario de Canarias; 🇪🇸 La Laguna, Tenerife, Spain

H. Nuestra Señora del Prado; 🇪🇸 Talavera de la Reina, Toledo, Spain

Hospital Clinic i Provincial; 🇪🇸 Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Vall D'Hebrón; 🇪🇸 Barcelona, Spain

Institut Catalá d'Oncologia de Girona; 🇪🇸 Gerona, Spain

H.U. Virgen de las Nieves; 🇪🇸 Granada, Spain

Complejo Hospitalario de Jaén; 🇪🇸 Jaén, Spain

Hospital de León; 🇪🇸 León, Spain

C.H.U. A Coruña; 🇪🇸 La Coruña, Spain

Hospital Xeral; 🇪🇸 Lugo, Spain

Hospital de Cabueñes; 🇪🇸 Gijón, Asturias, Spain

Hospital Costa del Sol; 🇪🇸 Marbella, Málaga, Spain

Hospital General del SAS de Jerez; 🇪🇸 Jerez de la Frontera, Cádiz, Spain

Hospital Son Llatzer; 🇪🇸 Mallorca, Spain

H. Basurto; 🇪🇸 Bilbao, Vizcaya, Spain

H.U. Nuestra Señora de Valme; 🇪🇸 Sevilla, Spain

H. Virgen de La Concha; 🇪🇸 Zamora, Spain

Hospital Universitario Arnau de Vilanova; 🇪🇸 Lérida, 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.U. Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hospital Morales Messeguer; 🇪🇸 Murcia, Spain

H. Carlos Haya; 🇪🇸 Málaga, Spain

Complexo Hospitalario de Ourense; 🇪🇸 Orense, Spain

Hospital Universitario Son Dureta; 🇪🇸 Palma de Mallorca, Spain

H. Universitario de Salamanca; 🇪🇸 Salamanca, Spain

H. General de Segovia; 🇪🇸 Segovia, Spain

H. Arnau de Vilanova; 🇪🇸 Valencia, Spain

H. Dr. Peset; 🇪🇸 Valencia, Spain

H. Clínico de Valencia; 🇪🇸 Valencia, Spain

H. Río Hortega; 🇪🇸 Valladolid, Spain

Hospital Clínico Universitario Valladolid; 🇪🇸 Valladolid, Spain

H. Nuestra Señora de Sonsoles; 🇪🇸 Ávila, Spain

H. Txagorritxu; 🇪🇸 Vitoria, Álava, Spain