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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Diffuse Large B-cell Lymphoma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| refractory/relapsed LDCBG<br>patients with refractory/relapsed diffuse large B-cell lymphoma | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diffuse large B-cell Lymphoma, R-IPI