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. 2024 May 21:2:38.
doi: 10.12688/openreseurope.14390.2. eCollection 2022.

Efficacy and safety of chimeric antigen receptor T-cell (CAR-T) therapy in hematologic malignancies: a living systematic review (protocol)

Leire Leache  1 , Marta Gutiérrez Valencia  1 , Luis Carlos Saiz  1 , Juan Erviti  1 , Maria Ximena Rojas Reyes  2
Affiliations

Efficacy and safety of chimeric antigen receptor T-cell (CAR-T) therapy in hematologic malignancies: a living systematic review (protocol)

Leire Leache et al. Open Res Eur. .

Abstract

Objective: To determine the efficacy and safety of CAR-T therapy in the treatment of patients with hematologic malignancies, in comparison with other current therapies.

Design: A living systematic review.

Methods: We will include randomized trials evaluating the effect of CAR-T therapy versus other active treatments, hematopoietic stem cell transplantation, best supportive care or any other intervention in patients with hematologic malignancies. Non-randomized primary studies will be searched in case we found no direct evidence from randomized controlled trials. Two reviewers will independently screen each study for eligibility, extract data, and assess the risk of bias. Efficacy measures will include overall survival rate, overall response rate, complete response/remission (CR) rate, partial response/remission (PR) rate, relapse from CR, progression-free survival, and time from CAR-T infusion to transplantation. Safety measures will include serious adverse events, the incidence of cytokine release syndrome, graft-versus-host disease, neurotoxicity, and total adverse events. Quality of life will also be assessed. Meta-analyses will be carried out to summarize the results. We will apply the GRADE approach to assess the certainty of the evidence for each outcome. A living, web-based version of this review will be openly available until there is solid evidence to respond to the review objective. We will resubmit it for publication every time the conclusions change or whenever there are substantial updates.

Keywords: Living systematic review; Chimeric Antigen Receptor T- Cell therapy; living evidence synthesis; hematologic malignancies; CAR-T infusion to transplantation..

Plain language summary

Research has been carried out over the last few years to assess the efficacy and usefulness of Chimeric Antigen Receptor T-Cell (CAR-T) therapy in hematologic malignancies. The present review aims to determine the efficacy and safety of CAR-T therapy in the management of patients suffering hematologic malignancies. Randomized controlled trials (RCT) that answer our research question or non-randomized primary studies, in case we found no direct evidence of RCT, will be retrieved. The Epistemonikos database will be used for the identification of potentially eligible studies. We will identify studies meeting our inclusion criteria. We will evaluate the risk of bias and the quality of the evidence will be determined with specific tools. We will monitor the newly published evidence every two months, searching for relevant studies that could indicate changes in the available evidence. This monitoring process will last until a high certainty of evidence is reached or at least 36 months.

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Conflict of interest statement

No competing interests were disclosed.

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