A Study to Evaluate Treatment Patterns and Investigate Adult Patients With B-cell Lymphoma

NCT07882576 — Not yet recruiting, 532 participants, AstraZeneca

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WW-CLARITY: Real-world Characteristics, Treatments, and Outcomes of Treatment-Naïve (TN) Patients With Diffuse Large B- Cell Lymphoma (DLBCL) in the UK, France, Canada, and Brazil

RegistryNCT07882576, acronym Clarity-BR
StatusNot yet recruiting
Study typeObservational
Enrollment532 (Estimated)
SponsorAstraZeneca (Industry)
ConditionsLymphoma, B-Cell
Datesstart 2026-11-30 (estimated), primary completion 2027-01-30 (estimated), completion 2027-01-30 (estimated), first posted 2026-10-20, last updated 2026-10-20
Locations5 sites in Brazil

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-Summary

This is a retrospective observational registry study designed to characterise patient profiles, assess treatment patterns, evaluate clinical outcomes and explore COO testing patterns among adult patients with newly diagnosed LDGCB who have not previously received treatment (TN) and are receiving first-line (1L) treatment.

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+Detailed description

This is a retrospective observational registry study designed to characterise patient profiles, assess treatment patterns, evaluate clinical outcomes and explore COO testing patterns among adult patients with newly diagnosed LDGCB who have not previously received treatment (TN) and are receiving first-line (1L) treatment. Patients who commenced first-line systemic treatment during the study identification period, from 1 January 2020 to one year prior to the end of the study period (which will vary according to the data source), will be eligible for inclusion in the study. Data will be collected, analysed and summarised separately for each participating country.

In Brazil, the study will use data available from the Study's Local Database - Einstein Hospital Israelita, including patient demographic data such as age and gender; clinical information such as diagnosis, disease stage, details of the patient's general condition and laboratory test results; and information on treatment.

+Outcome measures

Primary outcomes

  • Real-world progression-free survival (rwPFS), measured from the start of first-line (1L) treatment until clinically documented disease progression or death, with censoring at the time of the last contact. [through study completation, an avarege 1 year]: Probability of survival at 2 years derived from the Kaplan-Meier analysis of real-world rwPFS (2- year rwPFS)

Secondary outcomes

  • Distribution of first-line (1L) treatment regimens [through study completation, an avarege 1 year]: It will be summarized using descriptive statistics and Kaplan-Meier methods.
  • Safety outcomes include hematologic and non-hematologic adverse events. [through study completation, an avarege 1 year]: Safety will be assessed using adverse events that occurred during first-line treatment, with 95% confidence intervals.
  • Distribution of treatment patterns [through study completation, an avarege 1 year]: It will be summarized using descriptive statistics and Kaplan-Meier methods
  • Distribution of overall survival [through study completation, an avarege 1 year]: It will be summarized using descriptive statistics and Kaplan-Meier methods
  • Treatment time to next treatment or death [through study completation, an avarege 1 year]: It will be summarized using descriptive statistics and Kaplan-Meier methods

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients with newly diagnosed LDGCB prior to the index date during the study identification period (1 January 2020 to 1 July 2024) in registries/databases in Brazil, Canada, France and the United Kingdom.
* Patients aged ≥ 18 years at the time of their first diagnosis of LDGCB.
* Patients who started eligible first-line systemic therapy during the study identification period (1 January 2020 to 1 July 2024).
* Identify patients who started palliative care during the study identification period (1 January 2020 to 31 December 2024).

Exclusion Criteria:

* Patients who were treated for another primary cancer diagnosis documented less than 5 years prior to the index event.
* Patients who received systemic treatment for LDGCB prior to the index event.
* Patients who received palliative care as first-line treatment.
* Patients who participated in a clinical trial after the index date (i.e. who received treatment for LDGCB as part of a clinical trial)

+Locations (5)

FacilityCityCountryStatus
Hospital Erasto GaertnerCuritiba, ParanáBrazil
UNICAMPCampinas, São PauloBrazil
AC Camargo Cancer CenterSão PauloBrazil
Hospital Israelita Albert EinsteinSão PauloBrazil
Hospital Municipal da Vila Santa CatarinaSão PauloBrazil