Efficacy and safety of chimeric antigen receptor T-cell (CAR-T) therapy in hematologic malignancies: a living systematic review (protocol)
Creators
- 1. Unit of Innovation and Organization, Navarre Health Service, Pamplona, Tudela 20, 1st floor, 31003, Spain
- 2. Institut d'Recerca-Servei d'Epidemiologia Clínica i Salut Pública, Hospital de la Santa Creu i Sant Pau, Barcelona, Carrer de Sant Quintí, 08041, Spain
Description
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
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 will be considered for inclusion. If we find no direct evidence from randomized controlled trials, non-randomized primary studies will also be retrieved. Each of the identified studies will be independently assessed by two authors, both of whom will extract the information and evaluate the risk of bias. Efficacy measures 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 interval between CAR-T administration and transplantation. Safety measures will include: serious adverse events, 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. Quality of the evidence will be determined using the GRADE approach. A living version of the review will be accessible in an open manner until there is solid evidence to respond to the review objective. Updated versions of the evidence synthesis will be published whenever substantial modifications make it necessary.
Files
openreseurope-2-15530.pdf
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Additional details
References
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