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

Официальное название

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.

Обзор

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.

Первичные конечные точки

• To describe the treatment patterns for the first line and subsequent therapies for DLBCL patients [Срок оценки: 22 months]

Вторичные конечные точки (4)

• To describe the patient demographics and disease characteristics of DLBCL patients [Срок оценки: 22 Months]
• To identify and characterize patients according to risk profiles [Срок оценки: 22 Months]
• To explore access to novel therapies for DLBC [Срок оценки: 22 Months]
• Describing patients' risk profiles [Срок оценки: 22 Months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Египет · 5 центров

• Research Site — Al Mansurah
• Research Site — Alexandria
• Research Site — Cairo
• Research Site — Sohag
• Research Site — Tanta

Саудовская Аравия · 4 центра

• Research Site — Dammam
• Research Site — Jeddah
• Research Site — Riyadh
• Research Site — Riyadh

Turkey (Türkiye) · 4 центра

• Research Site — Ankara
• Research Site — Antalya
• Research Site — Istanbul
• Research Site — Izmir

Morocco · 2 центра

• Research Site — Casablanca
• Research Site — Rabat

Ирак · 1 центр

• Research Site — Baghdad

Иордания · 1 центр

• Research Site — Amman

Кувейт · 1 центр

• Research Site — Kuwait City

Oman · 1 центр

• Research Site — Muscat

Катар · 1 центр

• Research Site — Doha

ОАЭ · 1 центр

• Research Site — Abu Dhabi

Идентификаторы

NCT: NCT07065344 · D8220R00080

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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