Observational study to assess the characteristics and outcomes of patients with refractory/relapsed diffuse large B cell lymphoma who received R-GemOx as second line or above treatment (MK-2140-012)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Study drug and medical condition

• Medicinal product name, other:
  Rituximab-gemcitabine-oxaliplatin (R-GemOx)
• Study drug International non-proprietary name (INN) or common name:
  RITUXIMAB

  OXALIPLATIN
• Anatomical Therapeutic Chemical (ATC) code:
  (L01FA01) rituximab

  rituximab

  (L01XA03) oxaliplatin

  oxaliplatin

  (L01BC05) gemcitabine

  gemcitabine
• Medical condition to be studied:
  Diffuse large B-cell lymphoma

Population studied

• Short description of the study population:
  Adult participants with Refractory or Relapsed Diffuse large B-cell Lymphoma (R/R DLBCL), who received Rituximab-gemcitabine-oxaliplatin (R-GemOx) as 2nd-line or above treatment during the study identification period (January 01, 2015 through December 31, 2024).
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  This is a retrospective observational study of secondary data use, utilizing the structured and unstructured data of medical records from multi-centers (at least 4 selected tertiary hospitals).
• Main study objective:
  The main objectives are to evaluate the demographic and clinical characteristics, treatment characteristics, and clinical outcomes among patients with Refractory or Relapsed Diffuse large B-cell Lymphoma (R/R DLBCL), who initiated 2+ line treatment with R-GemOx, in China.
• Setting:
  Adult patients with Refractory or Relapsed Diffuse large B-cell Lymphoma (R/R DLBCL) included in medical records in multi-centers in China.
• Outcomes:
  Variable of clinical outcomes will be presented using real-world Response Rate (rwRR), real-world Duration of Response (rwDOR) real-world Progression Free Survival (rwPFS), real-world Overall Survival (rwOS), real-world Time to Treatment Discontinuation (rwTTD), and real-world Time to next treatment (rwTTNT).
• Data analysis plan:
  The analyses will be of descriptive nature in this study. The study is not aimed at testing any pre-specified hypothesis. Analyses will be performed by the sponsor upon the delivery of the validated dataset. Continuous variables (i.e., age) will be summarized using standard descriptive statistics, specifically mean, standard deviation, median, and range (minimum and maximum). Continuous variables may also be categorized into mutually exclusive groups (i.e., age categories) and examined as categorical or ordinal variables.