An observational study in Lymphoma, B-Cell, sponsored by AstraZeneca. Not yet recruiting at 5 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by AstraZeneca · Observational
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.
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.
1,415 studies on the registry are indexed under Lymphoma, B-Cell; 328 are open to participants now.
This study's planned enrollment of 532 is above the median of 153 across 128 observational studies indexed under Lymphoma, B-Cell.
Browse Lymphoma, B-Cell studies →AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population consists of adult patients with a recent diagnosis of LDGCB who have not previously received treatment (TN) and who commenced systemic 1L therapy during the study identification period (1 January 2020 to 1 July 2024) in Brazil, Canada, France and the United Kingdom. Patients will be followed up until death, loss to follow-up or the end of the study period, whichever occurs first. Loss to follow-up will be defined individually for each dataset, but may include (i) the last interaction recorded in the data, (ii) the end of the continuous recruitment period, or (iii) another definition specific to each dataset.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Probability of survival at 2 years derived from the Kaplan-Meier analysis of real-world rwPFS (2- year rwPFS)
Time frame: through study completation, an avarege 1 year
Distribution of first-line (1L) treatment regimens
It will be summarized using descriptive statistics and Kaplan-Meier methods.
Time frame: through study completation, an avarege 1 year
Safety outcomes include hematologic and non-hematologic adverse events.
Safety will be assessed using adverse events that occurred during first-line treatment, with 95% confidence intervals.
Time frame: through study completation, an avarege 1 year
Distribution of treatment patterns
It will be summarized using descriptive statistics and Kaplan-Meier methods
Time frame: through study completation, an avarege 1 year
Distribution of overall survival
It will be summarized using descriptive statistics and Kaplan-Meier methods
Time frame: through study completation, an avarege 1 year
Treatment time to next treatment or death
It will be summarized using descriptive statistics and Kaplan-Meier methods
Time frame: through study completation, an avarege 1 year
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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