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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Lalu, Manoj M. Kekre, Natasha Montroy, Joshua Ghiasi, Maryam Hay, Kevin McComb, Scott Weeratna, Risini Atkins, Harold Hutton, Brian Yahya, Ayel Masurekar, Ashish Sobh, Mohamad Fergusson, Dean A. |
| Abstract | Background Chimeric antigen receptor T cell therapy (CAR-T) represents a promising and exciting new therapy for hematologic malignancies, where prognosis for relapsed/refractory patients remains poor. Encouraging results from clinical trials have often been tempered by heterogeneity in response to treatment among patients, as well as safety concerns including cytokine release syndrome. The identification of specific patient or treatment-specific factors underlying this heterogeneity may provide the key to the long-term sustainability of this complex and expensive therapy. An individual patient data meta-analysis (IPMDA) may provide potential explanations for the high degree of heterogeneity. Therefore, our objective is to perform a systematic review and IPDMA of CAR-T cell therapy in patients with hematologic malignancies to explore potential effect modifiers of CAR-T cell therapy. Methods and analysis We will search MEDLINE, Embase, and the Cochrane Central Register of Controlled Clinical Trials. Studies will be screened in duplicate at the abstract level, then at the full-text level by two independent reviewers. We will include any prospective clinical trial of CAR-T cell therapy in patients with hematologic malignancies. Our primary outcome is complete response, while secondary outcomes of interest include overall response, progression-free survival, overall survival, and safety. IPD will be collected from each included trial and, in the case of missing data, corresponding authors/study sponsors will be contacted. Standard aggregate meta-analyses will be performed, followed by the IPD meta-analysis using a one-stage approach. A modified Institute of Health Economics tool will be used to evaluate the risk of bias of included studies. Ethics and dissemination Identifying characteristics that may act as modifiers of CAR-T cell efficacy is of paramount importance and can help shape future clinical trials in the field. Results from this study will be submitted for publication in a peer-reviewed scientific journal, presented at relevant conferences and shared with relevant stakeholders. |
| Related Links | https://systematicreviewsjournal.biomedcentral.com/counter/pdf/10.1186/s13643-022-02158-1.pdf |
| Ending Page | 7 |
| Page Count | 7 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| ISSN | 20464053 |
| DOI | 10.1186/s13643-022-02158-1 |
| Journal | Systematic Reviews |
| Issue Number | 1 |
| Volume Number | 12 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2023-01-19 |
| Access Restriction | Open |
| Subject Keyword | Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Systematic review Individual patient data meta-analysis CAR-T cell therapy Oncology Protocol Medicine/Public Health |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine |
| Journal Impact Factor | 6.3/2023 |
| 5-Year Journal Impact Factor | 4.5/2023 |
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