Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy

Authors

  • Matilde Lencastre Department of Transplantation Medicine, Sotavento Centre for Experimental Therapeutics, Tavira, Portugal Author
  • Nadine Xuereb Centre for Clinical Trials Methodology, Qormi Institute of Translational Medicine, Qormi, Malta Author
  • Corinne Ineichen Department of Early Phase Research, Leventina Centre for Molecular Therapeutics, Airolo, Switzerland Author

DOI:

https://doi.org/10.5281/zenodo.22649445

Keywords:

Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy;, Translational medicine; Evidence synthesis; Clinical implementation; Health services research

Abstract

Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy is an area of active
development in translational medicine, with evidence that has accumulated unevenly across its component questions. We review
the current evidence base for protocol for a randomised withdrawal study of long-term immunosuppression after cell therapy,
spanning analytical, clinical, implementation, governance, and economic dimensions, focusing on where practice has converged
and where it continues to vary, and set out the practical considerations relevant to a service considering its adoption. We conclude
that selective, context-specific use is best supported by the evidence currently available, rather than uniform adoption or
avoidance.

References

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Brankovic K, Kowalczyk B, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a methodological appraisal". Clin Pharmacol Ther 10(2014): 91-98. DOI: 10.1007/s00330-025-12031-z

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Farkas I, Ionescu F, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a consensus statement". Clin Cancer Res 18(2011): 135-146. DOI: 10.7759/cureus.46454

Grabowski P, Petrescu G, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a retrospective analysis". BMJ Open 20(2014): 146-158. DOI: 10.1016/j.ssci.2025.107028

Hendriksen W, Wojcik H, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a validation study". J Clin Epidemiol 22(2017): 157-170. DOI: 10.2196/48633

Ionescu F, Foscarini I, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a scoping review". Contemp Clin Trials 24(2020): 168-182. DOI:

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Kowalczyk N, Novotna K, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a systematic review". Br J Clin Pharmacol 28(2011): 190-197. DOI: 10.17219/acem/208596

Lindqvist U, Urbanek L, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a methodological appraisal". PLoS Med 30(2014): 201-209. DOI: 10.7759/cureus.104086

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Ristic C, Castellani R, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a validation study". Clin Transl Sci 42(2017): 267-281. DOI: 10.1007/s10916-024-02104-9

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Wojcik H, Hendriksen W, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a multicentre analysis". BMC Med 12(2017): 322-332. DOI: 10.2196/48297

Zielinski O, Ostrowski Z, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a prospective cohort study". Sci Transl Med 14(2020): 333-344. DOI: 10.1007/s00330-025-12031-z

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Chiriac F, Farkas C, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a retrospective analysis". Nat Rev Drug Discov 20(2014): 366-380. DOI: 10.2196/69678

Doncheva M, Marchetti D, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a validation study". Trials 22(2017): 377-383. DOI: 10.7759/cureus.46454

Emmerich T, Tarasov E, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a scoping review". Drug Discov Today 24(2020): 388-395. DOI: 10.1016/j.ssci.2025.107028

Foscarini C, Chiriac F, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a health-economic analysis". Clin Cancer Res 26(2023): 399-407. DOI: 10.2196/48633

Alvez D, Dumitrescu A, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a systematic review". BMJ Open 28(2011): 410-419. DOI: 10.1371/journal.pone.0305949

Brankovic K, Kowalczyk B, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a methodological appraisal". J Clin Epidemiol 30(2014): 421-431. DOI: 10.1371/journal.pdig.0000514

Castellani R, Ristic C, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a multicentre analysis". Contemp Clin Trials 32(2017): 432-443. DOI: 10.17219/acem/208596

Dumitrescu A, Andric D, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a prospective cohort study". Ther Innov Regul Sci 34(2020): 443-455. DOI: 10.7759/cureus.104086

Eriksdottir B, Brankovic E, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a randomised evaluation". Br J Clin Pharmacol 36(2023): 454-467. DOI: 10.1038/s41746-023-00852-5

Farkas I, Ionescu F, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a consensus statement". PLoS Med 38(2011): 465-479. DOI: 10.1016/j.mayocpiqo.2022.09.004

Grabowski P, Petrescu G, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a retrospective analysis". Lancet 40(2014): 476-482. DOI: 10.1177/08404704241291226

Hendriksen W, Wojcik H, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a validation study". N Engl J Med 42(2017): 487-494. DOI: 10.1093/medlaw/fwad013

Ionescu F, Foscarini I, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a scoping review". JAMA 44(2020): 498-506. DOI: 10.2196/89834

Jankowiak G, Grabowski J, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a health-economic analysis". Nat Med 46(2023): 509-518. DOI: 10.1007/s10916-024-02104-9

Kowalczyk N, Novotna K, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a systematic review". Cell Rep Med 8(2011): 520-530. DOI: 10.3389/fdgth.2026.1896184

Lindqvist U, Urbanek L, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a methodological appraisal". Clin Transl Sci 10(2014): 531-542. DOI: 10.3390/diagnostics15162117

Marchetti D, Doncheva M, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a multicentre analysis". Pharmacogenomics J 12(2017): 542-554. DOI: 10.4103/jrpp.jrpp_20_65

Novotna E, Eriksdottir N, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a prospective cohort study". Regul Toxicol Pharmacol 14(2020): 553-566. DOI: 10.3389/fdgth.2026.1763884

Ostrowski L, Lindqvist O, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a randomised evaluation". Drug Saf 16(2023): 564-578. DOI: 10.2196/48297

Petrescu S, Szabo P, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a consensus statement". Ann Intern Med 18(2011): 575-581. DOI: 10.1007/s00330-025-12031-z

Quintero B, Balogh Q, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a retrospective analysis". BMC Med 20(2014): 586-593. DOI: 10.3389/fdgth.2026.1699005

Ristic C, Castellani R, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a validation study". Sci Transl Med 22(2017): 597-605. DOI: 10.3389/fdgth.2026.1834800

Szabo J, Jankowiak S, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a scoping review". J Transl Med 24(2020): 608-617. DOI: 10.2196/69678

Tarasov Q, Quintero T, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a health-economic analysis". Clin Pharmacol Ther 26(2023): 619-629. DOI: 10.7759/cureus.46454

Urbanek Z, Zielinski U, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a systematic review". Nat Rev Drug Discov 28(2011): 630-641. DOI: 10.1016/j.ssci.2025.107028

Vasquez A, Alvez V, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a methodological appraisal". Trials 30(2014): 641-653. DOI: 10.2196/48633

Wojcik H, Hendriksen W, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a multicentre analysis". Drug Discov Today 32(2017): 652-665. DOI: 10.1371/journal.pone.0305949

Zielinski O, Ostrowski Z, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a prospective cohort study". Clin Cancer Res 34(2020): 663-677. DOI: 10.1371/journal.pdig.0000514

Andric V, Vasquez A, et al. "Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy: a randomised evaluation". BMJ Open 36(2023): 674-680. DOI: 10.17219/acem/208596

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Published

2025-12-11

How to Cite

Protocol for a Randomised Withdrawal Study of Long-Term Immunosuppression After Cell Therapy. (2025). Translational Medicine & Therapeutics Journal, 4(2), 101-109. https://doi.org/10.5281/zenodo.22649445

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