An observational study in Hematology and Diffused Large B Cell Lymphoma, sponsored by AstraZeneca. Recruiting at 21 sites in 10 countries. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by AstraZeneca · Observational
Non-Hodgkin lymphoma (NHL) is the most common hematologic malignancy, with over 80,500 estimated new cases diagnosed in the United States in 20231. Diffuse large B-cell lymphoma (DLBCL) is the most frequent subtype of NHL, accounting for 30%-40% of cases2. DLBCL is an aggressive malignancy with heterogeneous biology and behavior. Disease risk stratification and treatment planning involve various patient and clinical characteristics (e.g., age, stage, and tumor bulk), prognostic indices (e.g., International Prognostic Index (IPI) score), and gene expression profiling. Patients typically present with nodal or extranodal disease, usually exhibiting rapid tumor growth and symptoms that are highly dependent upon the tumor localization.
The diagnosis and subtyping of DLBCL have significantly advanced, from morphological assessment of tissue slide to numerous ancillary tests, including immunophenotyping performed by immunohistochemistry (IHC), cytogenetics, and detailed molecular testing to classify the disease based on cell of origin (COO). With the advent of novel therapeutic options, molecular subtyping of DLBCL at diagnosis is expected to allow prognostic stratification of patients into distinct subgroups. This stratification could provide a preclinical rationale for therapeutic targeting the involved pathways and paving the application of personalized treatment.
DLBCL is a potentially curable disease with an overall 60-70% chance of achieving durable complete remission (CR) with the currently used standard first-line immunochemotherapy. However, 30-40% of patients are either refractory to first-line treatment or experience relapse and eventually will die of disease progression7. Although high-dose chemotherapy followed by autologous stem cell transplant (ASCT) is the recommended SOC for eligible patients in the second-line setting based on results from the pivotal PARMA study, real-world SOC in this setting remains less clearly defined.
Patients not cured with ASCT or ineligible to ASCT or refractory to salvage chemotherapy may be considered for Chimeric Antigen Receptor (CAR) T cell therapy targeting CD1910. Although ASCT and CAR-T cell therapy offer patients an opportunity for durable remission, many patients may not be eligible for ASCT or CAR-T cell therapy or relapse after these treatments. In the last decade, the investigation of novel antigens, which can be targeted by immunotherapy and identified to eliminate malignant cells regardless of their molecular pathogenesis, has been constantly pursued.
This study aims to address this need by examining the demographic, clinical characteristics, and treatment patterns and exploring access to novel therapies for diffuse large B-cell lymphoma (DLBCL) patients, both treatment naïve and relapsed/refractory patients, in the Middle East and Africa (MEA) region.
885 studies on the registry are indexed under Lymphoma, B-Cell; 286 are open to participants now.
This study's planned enrollment of 500 is above the median of 150 across 69 observational studies indexed under Lymphoma, B-Cell.
Browse Lymphoma, B-Cell studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study aims to recruit approximately 500 patients, divided as follows:
Patients will be selected based on strict inclusion and exclusion criteria to ensure the validity and reliability of the study results. The study will be conducted across eight countries in the Middle East and Africa (MEA) region, including Egypt, South Africa, Turkey, Iraq, Morocco, and the Gulf Cooperative Council (GCC), including the Kingdom of Saudi Arabia (KSA), the United Arab Emirates (UAE), and Kuwait.
Approximately 15-20 sites within these countries will participate in the study.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
333 patients treatment naïve, treatment-eligible DLBCL patients
167 patients relapsed and/or refractory DLBCL patients who have failed at least one prior therapy.
To describe the treatment patterns for the first line and subsequent therapies for DLBCL patients
▪ Type of regimen: Chemoimmunotherapy "CIT" and regimen name, targeted therapies and name, bone marrow transplantations (BMT), T-cell engagers and name, and CAR-T cell therapy and name, Antibody Drug Conjugate (ADC) and Name, Anti-CD79b (Polatuzumab), Anti-CD-19 (Tafasitamab).
Time frame: 22 months
To describe the patient demographics and disease characteristics of DLBCL patients
\- Patient demographics: * Age * Gender * Ethnicity
Time frame: 22 Months
To identify and characterize patients according to risk profiles
Describing patients' risk profiles, including: \- Cytogenetic aberrations
Time frame: 22 Months
To explore access to novel therapies for DLBC
Exploring access to novel therapies for DLBCL: ▪ Proportion (%) of patients receiving the prescribed novel therapies
Time frame: 22 Months
Describing patients' risk profiles
Immunohistochemistry results (Positive/Negative/Unknown)
Time frame: 22 Months
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 rerefer 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. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
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