DLBCL - Diffuse Large B Cell Lymphoma, Markers of Inflammation
Conditions
Keywords
DLBCL, CRP To Albumin Ratio, CAR, modified Glassgow Prognostic Score, mGPS
Brief summary
This observational study evaluates the predictive value of systemic inflammatory markers-CRP, albumin, CRP-to-albumin ratio (CAR), and modified Glasgow Prognostic Score (mGPS)-in patients with diffuse large B-cell lymphoma (DLBCL) receiving R-CHOP chemotherapy. The study examines associations with treatment response, toxicity, and clinical characteristics.
Detailed description
This prospective cohort study investigates the predictive significance of systemic inflammatory markers-CRP, serum albumin, CRP-to-albumin ratio (CAR), and modified Glasgow Prognostic Score (mGPS)-in patients with diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP chemotherapy. The study aims to assess correlations between these markers and treatment outcomes, including objective response rate (ORR) and treatment-related toxicity. Inflammatory markers will be measured at baseline and after three chemotherapy cycles. Treatment response will be evaluated using Lugano classification criteria, and toxicity will be assessed per CTCAE version 5.0. The study also explores associations with clinical characteristics such as disease stage and performance status, aiming to enhance prognostic modeling and support personalized treatment strategies in DLBCL.
Interventions
DRUGObservational Assessment of Standard R-CHOP Treatment
Patients will receive R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) as part of routine clinical care. The study does not assign or modify treatment. Data will be collected to assess the association between inflammatory markers and clinical outcomes.
Sponsors
Ain Shams University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years and ≤ 65 years * Pathologically confirmed, treatment-naïve diffuse large B-cell lymphoma (DLBCL) * Any stage of disease (nodal or extra-nodal), with or without B symptoms * Scheduled to receive standard systemic treatment (R-CHOP) * ECOG performance status 0-2 * Baseline normal: * Complete blood count (CBC) * Hepatitis viral markers * Liver and renal function tests * Urine analysis * Echocardiogram * Additional investigations to exclude current infection if clinically indicated
Exclusion criteria
* History of other concurrent or previous malignancies * Relapsed or refractory DLBCL * Uncontrolled comorbid conditions that may interfere with study participation, including: * Diabetes mellitus * Autoimmune diseases * Active infections * Chronic inflammatory diseases * Cardiac dysfunction * Liver cell failure * Pregnant females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) Following 3 Cycles of R-CHOP Based on Baseline Inflammatory Markers | Baseline (Day 1 of Cycle 1) and Day 63 (End of Cycle 3; each cycle is 21 days) | Proportion ( %) of patients achieving an objective response (complete or partial) according to the Lugano classification after three cycles of R-CHOP chemotherapy. Patients will be stratified by baseline inflammatory markers: * C-reactive protein (CRP, mg/L, measured by immunoturbidimetric assay) * Serum albumin (g/dL, measured by colorimetric assay) * CRP/Albumin ratio (CAR, calculated as CRP divided by albumin) * Modified Glasgow Prognostic Score (mGPS, range 0-2) Response will be assessed using PET/CT imaging. |
| Incidence of Treatment-Related Toxicity During Initial Treatment According to Baseline Inflammatory Markers | Day 1 of Cycle 1 through Day 63 (End of Cycle 3; each cycle is 21 days) | Incidence (%) of patients experiencing any-grade treatment-related adverse events during the first three cycles of R-CHOP, stratified by baseline CRP, albumin, CAR, and mGPS. Toxicity will be graded according to CTCAE version 5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients in Each IPI Risk Category by Baseline Inflammatory Marker Levels | Day 1 of Cycle 1 (each cycle is 21 days) | Proportion (%) of patients in each International Prognostic Index (IPI) risk category (low, intermediate, high), stratified by baseline inflammatory markers: * CRP (mg/L, measured by immunoturbidimetric assay) * Albumin (g/dL, measured by colorimetric assay) * CRP/Albumin ratio (CAR, calculated as CRP divided by albumin) * Modified Glasgow Prognostic Score (mGPS, range 0-2) IPI will be calculated based on age, LDH level, Ann Arbor stage, ECOG performance status, and extranodal involvement. |
Countries
Egypt
Contacts
Primary ContactAlaa M Elsayed, MSc
Outcome results
None listed