View clinical trials related to Diffuse Large B-Cell Lymphoma.
Filter by:This retrospective cohort study, based on the French medico-administrative database (SNDS), evaluated the care pathway, the effectiveness of management and the costs associated with patients treated with chimeric antigen receptor (CAR) T cells (CART-cells) (KYMRIAH or YESCARTA): paediatric and young adult patients (up to and including 25 years of age) with acute lymphoblastic leukaemia (ALL); and adult patients (18 years of age or older) with DLBCL.
This was a retrospective non-interventional cohort study design using the Centers for Medicare and Medicaid Services (CMS) 100% Medicare data (2015Q1-2020Q4). Eligible adult patients with r/r DLBCL who were treated with CAR-T therapy were identified from the CMS 100% Medicare data. Patients who received chimeric antigen receptor modified T cell (CAR-T) therapy were further classified into tisa-cel and axi-cel cohorts based on the type of CAR-T treatment received. The index date was defined as the date of tisa-cel or axi-cel therapy administration. Baseline period was defined as three months prior to the index date. Study period was defined from the index date to the end of health plan coverage based on insurance enrollment file or death, whichever occurred earlier.
A retrospective, non-interventional cohort study was used to address the study objectives. This study aimed to provide a better understanding of real-world healthcare resource utilization (HRU) and healthcare reimbursement costs associated with chimeric antigen receptor modified T cell (CAR-T) therapy among patients with DLBCL.
This is a non-interventional, retrospective cohort study using the Flatiron Health Research Database (FHRD) and data from the single-arm phase II JULIET clinical trial (NCT02445248).
Primary Objective: To evaluate objective response rate (ORR) in adult patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL) who receive systemic treatment after at least 2 prior systemic therapies in the real-world setting according to Lugano classification of malignant lymphoma (Cheson, 2014) and as assessed by independent central review Secondary Objectives: To evaluate the following outcomes in adult patients with r/r DLBCL who are treated with currently available therapies in the real-world setting: 1. ORR according to Lugano classification and as assessed by treating physician evaluation 2. Complete Response (CR) rate according to Lugano classification and as assessed by: - Independent central review, and - Treating physician evaluation 3. Progression Free Survival (PFS) according to Lugano classification and as assessed by: - Independent central review, and - Treating physician evaluation 4. Overall Survival (OS) 5. Duration of response (DOR) according to Lugano classification and as assessed by - Independent central review and - Treating physician evaluation 6. Disease control rate (DCR) according to Lugano classification and as assessed by: - Independent central reviewed - Treating physician evaluation 7. Time to next treatment (TTNT)
Diffuse Large B-cell Lymphoma (DLBCL) is a malignant, aggressive lymphoid cancer. The incidence in Denmark is approximately 450 cases per year. In 2/3 of the cases, complete remission is achieved with immunochemotherapy. The remaining 30% will experience relapse and in 5 % of the patients, this will occur in the central nervous system (CNS). CNS relapse has a very poor prognosis with an overall survival of 3-6 months. In order to identify patients at risk of CNS relapse, the CNS-IPI score is used to stratify the patients into three risk groups according to number of risk factors (low 0-1, middle 2-3 and high risk 4-6 which corresponds to 2-year CNS relapse rates of 0,6%, 3,4% and 10,2% respectively). DLBCL can be subdivided by gene expression analysis into three different types based on the cell of origin (ie the stage of the equivalent normal cell development from which the disease arises): the germinal center B-cell (GCB)-like subtype, the activated B-cell (ABC)-like subtype and unclassifiable. The subdivision is of prognostic importance as patients with GCB-like subtype have a 5-year OS of 76% vs 34% in the non-GCB group. Furthermore, studies have found a higher risk of CNS relapse in the ABC-like subtype compared to the GCB subtype0. Other gene rearrangements of potential importance to the risk of CNS relapse is "double hit" (DHL) (5-10% of newly diagnosed DLBCL patients) and MYC/BCL2 co-expressors (double expressors, DEL). Chemotherapeutic CNS prophylaxis is recommended based on the CNS-IPI stratification for the high-risk group (CNS-IPI 4-5) due to an estimated risk of CNS relapse of 10,2%. However, a relapse risk with a specificity of 10,2% results in almost 90% of the patients potentially receiving 'unnecessary' prophylactic chemotherapy with toxic side effects. One study published on data from the GOYA-trial have integrated COO into the CNS-IPI and found an increased sensitivity with a two year relapse risk of 15,2% in the high risk group. In this study we aim to validate the CNS-IPI and evaluate whether the addition of biomarkers for cell of origin (COO) and double hit (DH) DLBCL improves the prediction of later CNS relapse. This will be done through analysis of patientdata from the Danish nationwide lymphoma database, LYFO, on all patients with DLBCL diagnosed from 1.1.2014 to 1.1.2021 combined with pathology reports from the Danish Pathology registry.
The main objective of the trial is to assess the efficacy and tolerability of Lonca-R in unfit and frail participants with previously untreated DLBCL.
This will be a cohort study of all patients receiving Cluster of Differentiation 19 (CD19)-specific CAR T cell therapy for relapsed/refractory B cell haematological malignancies. Patients will receive cardiac assessment and have serum cardiac biomarkers, ECG, transthoracic echocardiogram and cardiac magnetic resonance imaging performed at baseline prior to CAR T cell therapy, 7 days post CAR T cell infusion, and 3 months post CAR T cell infusion. Abnormalities in these cardiac investigations will be used to demonstrate cardiac injury and identify which patients are most at risk of developing cardiac injury related to CAR T cell therapy.
This retrospective study aimed to investigate the combined prognostic values of intratumoral metabolic heterogeneity (MH), disseminate feature (Dmax) and total metabolic tumor volume (TMTV) by 2-deoxy-2-[18F]fluoro-D-glucose positron emission tomography/computed tomography ([18F]FDG PET/CT), and establish novel nomograms to improve prognosis prediction in diffuse large B-cell lymphoma (DLBCL)
The RTXM83-AC-01-11 study evaluated efficacy and safety outcomes in relation to the use of Vivaxxia during 6 treatment cycles (at the investigator's discretion, up to 8 treatment cycles could be administered), followed by 9 months of follow-up. , this follow-up time being sufficient for the analysis of non-inferiority in relation to the reference medicine. However, data on late events of efficacy and safety are of great value to contribute to a robust clinical response and to strengthen confidence in the use of biosimilar medicines. For this reason, Libbs Farmacêutica proposes this retrospective observational study to collect data on late outcomes of the pivotal study that directed the approval of the biosimilar rituximab (Vivaxxia) from the research participants from Brazil. The present retrospective observational study LB2002 will sub-analyze selected results of efficacy and safety from study RTXM83-AC-01-11 in participants over 18 years of age randomized in Brazil, totaling 28 participants, in addition to evaluating late efficacy and safety outcomes. Information on subsequent treatment / protocol should also be collected for participants who have progressive or recurrent disease, instituted by research centers under these conditions. The proposal is to compare descriptively the selected outcomes of efficacy and safety of these participants with the same outcomes selected for the global population in the RTXM83-AC-01-11 study, and also provide late safety and effective data important for anti-neoplastic processes.