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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diffuse Large B-cell Lymphoma
- Sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Enrollment
- 158
- Locations
- 56
- Primary Endpoint
- R-IPI Index (Revised International Prognostic Index)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
R-IPI Index (Revised International Prognostic Index)
Time Frame: 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.
Predictive Value of R-IPI at Diagnosis
Time Frame: At diagnosis
Secondary Outcomes
- p-53 Expression(At diagnosis)
- p53 Expression(At the beginning of the 2nd line of treatment)
- Multiple Myeloma Oncogene 1 (MUM-1) Expression(At diagnosis)
- Bcl-2 Expression(At the beginning of the 2nd line of treatment)
- Bcl-6 Expression(At the beginning of the second line of treatment)
- MUM-1 Expression(At the beginning of the 2nd line of treatment)
- Ann Arbor Staging(At the beginning of the 2nd line of treatment)
- Response to First Line of Treatment(After first line treatment)
- Response to Second Line of Treatment(After second line of treatment)
- Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis(At diagnosis)
- Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis(At diagnosis)
- Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis(At diagnosis)
- Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status(At the beginning of the 2nd line of treatment)
- Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis(At diagnosis)