HematologyDOMAINNCT07065344
A Multicenter Observational Study to Understand the Clinical Characteristics, Treatment Patterns and Access to Novel Therapies of Patients With Diffuse Large B-Cell Lymphoma in the MEA Region
An observational study of Hematology and Diffused Large B Cell Lymphoma, run by AstraZeneca at 21 sites in 10 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematology, Diffused Large B Cell Lymphoma
- How many people
- 500 participants
- Where
- 21 sitesin 10 countries
- Study dates
- 23 Jul 2025to 31 Jan 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study aims to recruit approximately 500 patients, divided as follows: * Cohort 1: 333 patients treatment naïve, treatment-eligible DLBCL patients. * Cohort 2: 167 patients relapsed and/or refractory DLBCL patients who have failed at least one prior therapy. 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.
Who may be able to join
- Male or female patients aged 18 years or older at diagnosis.
- Patients who have confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) according to the investigator's decision and/or histopathological diagnosis.
- For Cohort 1: DLBCL patients who are eligible to start treatment* according to the investigator's decision.
- For Cohort 2: patients who are diagnosed with DLBCL and have failed at least one prior line of therapy.
- Patients willing to sign the written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation.
Who cannot join
- Patients who are not eligible for treatment for any reason, according to the investigator's judgment and decision
- Patients with concurrent active malignancies other than DLBCL.
- Patients who are actively participating in any other clinical trial.
Trial locations and contacts
21 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
21 sites in 10 countries
Egypt5 sites, 5 recruiting
- Not yet recruiting
Research Site
Al Mansurah
- Not yet recruiting
Research Site
Alexandria
- Not yet recruiting
Research Site
Cairo
- Not yet recruiting
Research Site
Sohag
- Not yet recruiting
Research Site
Tanta
Saudi Arabia4 sites, 4 recruiting
- Recruiting
Research Site
Dammam
- Recruiting
Research Site
Jeddah
- Recruiting
Research Site
Riyadh
- Not yet recruiting
Research Site
Riyadh
Turkey (Türkiye)4 sites, 4 recruiting
- Recruiting
Research Site
Ankara
- Recruiting
Research Site
Antalya
- Recruiting
Research Site
Istanbul
- Recruiting
Research Site
Izmir
Morocco2 sites, 2 recruiting
- Not yet recruiting
Research Site
Casablanca
- Not yet recruiting
Research Site
Rabat
United Arab Emirates1 site, 1 recruiting
- Recruiting
Research Site
Abu Dhabi
About this study
Official title: A Multicenter Observational Study to Understand the Clinical Characteristics, Treatment Patterns and Access to Novel Therapies of Patients With Diffuse Large B-Cell Lymphoma in the MEA Region A Cross-sectional Multi-center, Observational Study to Describe the Disease Characteristics and Treatment Patterns and Explore Access to Novel Therapies for Diffuse Large B-Cell Lymphoma (DLBCL) Patients for Both Treatment naïve and Relapsed/Refractory Patients in the Middle East & Africa (MEA) Region.
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.
Read more
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.
- Conditions
- Hematology, Diffused Large B Cell Lymphoma
- Keywords
- Diffused Large B Cell Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| - Cohort 1: Treatment naïve, treatment-eligible (according to investigator's decision) DLBCL. | 333 patients treatment naïve, treatment-eligible DLBCL patients | |
| - Cohort 2: Relapsed/Refractory DLBCL who have failed at least one prior therapy. | 167 patients relapsed and/or refractory DLBCL patients who have failed at least one prior therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 22 months
Secondary outcomes (4)
To describe the patient demographics and disease characteristics of DLBCL patients
- Patient demographics:
- Age
- Gender
- Ethnicity
Measured: 22 Months
To identify and characterize patients according to risk profiles
Describing patients' risk profiles, including:
- Cytogenetic aberrations
Measured: 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
Measured: 22 Months
Describing patients' risk profiles
Immunohistochemistry results (Positive/Negative/Unknown)
Measured: 22 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start23 Jul 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematologyStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065344
- Sponsor's protocol ID
- D8220R00080
- Acronym
- DOMAIN
- Status last verified
- Sep 2026
- First submitted
- 26 May 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.