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Although the initial clinical remission rates after CAR T cell therapy in all patients are as high as 90%, [100] long-term survival rates are much lower. The cause is typically the emergence of leukemia cells that do not express CD19 and so evade recognition by the CD19–CAR T cells, a phenomenon known as antigen escape. [33]
CD19 is widely expressed during all phases of B cell development until terminal differentiation into plasma cells. During B cell lymphopoiesis, CD19 surface expression starts during immunoglobulin (Ig) gene rearrangement, which coincides during B lineage commitment from hematopoietic stem cell. [8]
Anti-CD19 (CD19 is crucial for B cell lineage, which is overexpressed on leukemic B-cells) is the most commonly used and effective CAR in ALL treatments. Many clinical studies have reported its efficacy with satisfying complete and partial remission rates (CR and PR). [ 8 ]
The DRKS is an open access, free of charge online register for clinical trials and is available both in English and German. DRKS is part of the WHO's ICTRP. The DRKS works with two partner registries in Germany, DeReG (German Registry for Somatic Gene-Transfer Trials) and Clinical Trial Registry of the University Medical Center Freiburg. [4]
As a result of pressure from HIV-infected men in the gay community, [citation needed] who demanded better access to clinical trials, the U.S. Congress passed the Health Omnibus Programs Extension Act of 1988 (Public Law 100-607) [2] which mandated the development of a database of AIDS Clinical Trials Information Services (ACTIS). [3]
EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European clinical trials database of all clinical trials of investigational medicinal products with at least one site in the European Union commencing 1 May 2004 or later. The EudraCT database has been established in accordance with Directive 2001/20/EC.
SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).
The Clinical Practice Research Datalink (CPRD) is an observational and interventional research service that operates as part of the Department of Health and Social Care.It is jointly funded by the National Institute for Health and Care Research (NIHR) and the Medicines and Healthcare products Regulatory Agency (MHRA).