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This necessitates specialized and continuous post-treatment care, which is currently insufficiently standardized and still largely delivered predominantly through in-person and nonintegrated processes. We aimed to develop a comprehensive and innovative post-treatment care program for patients after alloHCT and CAR T-cell therapy based on an interdisciplinary, digitally supported, cross-regional and, cross-sectoral approach, and to evaluate its effectiveness in a randomized controlled trial (RCT). Developed by a multidisciplinary team, the intervention involves case managers and home visits by onco nurses, supported by digital components. These include patient-reported monitoring of vital signs and symptoms via a mobile application, video consultations, and virtual case conferences with community-based hematologists. The evaluation of effectiveness includes both quantitative outcomes, such as mortality and rehospitalization rates, and qualitative data derived from semi-structured interviews. The required ethics approvals were obtained in due time, and the three study centers were successfully initiated in 2024. As of January 2026, recruitment has been completed, and a total of 306 patients were successfully enrolled and randomized in a 1:1 ratio to receive either the SPIZ intervention or routine care. Funded and supported by the Federal Joint Committee (G-BA), a positive evaluation could facilitate the integration of the proposed care model into routine clinical practice, thereby strengthening post-treatment care for patients undergoing cellular therapy across Germany.<\/jats:p>","DOI":"10.1007\/s00277-026-07290-9","type":"journal-article","created":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T05:34:19Z","timestamp":1790400859000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["The SPIZ study: rationale and protocol of a randomized controlled trial to optimize interdisciplinary care of patients following cellular therapy through a digitally supported, cross-regional and cross-sectoral care model"],"prefix":"10.1007","volume":"105","author":[{"given":"Martin M. 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VV received research funding from Gilead\/Kite and Amgen. He is member of scientific advisory boards from Johnson&Johnson, Amgen, Abbvie, Sobi, Gilead\/Kite, BMS\/Celgene. He is receiving honoraria from Novartis, Roche, Johnson&Johnson, Gilead\/Kite, Elli Lilly, AstraZeneca and travel support from Gilead\/Kite, AstraZeneca and Johnson&Johnson. J.Schm. in addition to this project, received institutional funding for investigator-initiated research from the GB-A, the BMG, the BMFTR, the Free State of Saxony, Novartis, Sanofi, ALK, and Pfizer. He served as a consultant at advisory board meetings for Sanofi, Lilly, and ALK and received a personal honorarium for this work. M.B. declares consulting services for Jazz, MSD and ActiTrexx. J.M.M declares consulting services for Janssen, Roche, Gilead, Abbvie, Jazz, Pfizer, Astellas, Novartis, AstraZeneca and Clycostem. Furthermore, he holds shares in Cancilico and Synagen, has received institutional research grants by Janssen, Jazz and Novartis and has received honoraria by Novartis, Roche, Janssen, Abbvie, Pfizer, Sanofi, Astellas and Beigene. K.E.H received funding from G-BA Innovation funds and H.W. Hector-Foundation. She received travel support from Incyte, Johnson&Johnson, Servier and Sanofi, honoraria from Bristol Myers Squibb and compensation as a member of the scientific advisory board from Sanofi and Beigene. All other authors have nothing to declare.","order":1,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"German Clinical Trials Register (DRKS-ID: DRKS00034454) on January, 31, 2025 (https:\/\/drks.de\/search\/en\/trial\/DRKS00034454).","order":2,"name":"Ethics","label":"Trial registration","group":{"name":"EthicsHeading","label":"Declarations"}}],"article-number":"429"}}