Clinical trial · Observational
Central Nervous System Disorders Following Hematopoietic Stem Cell Transplantation
Central Nervous System Disorders Following Hematopoietic Stem Cell Transplantation: a Prospective Observational Trial From the Infectious Diseases Working Party and the Transplant Complications Working Party of the European Society for Blood and Marrow Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
All patients undergoing allogeneic or autologous HSCT at the participating centres will be observed. Once a diagnosis of CNS disorder is made, additional data will be reported for these patients. We will identify clinical and diagnostic characteristics such as cerebrospinal fluid (CSF) and neuroimaging patterns, risk factors, response to treatment (including novel antifungal agents such as isavuconazole) and outcome. In addition, risk factors for CNS disorders after allogeneic and autologous HSCT will be analyzed using a prospectively assessed matched control group. In the future, this study might be the basis for an interventional trial (e.g. using a prophylactic approach).
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blood Cancer | Liquid Tumor | ALIAS | 0.90 |
| Blood Disease | — | UNRESOLVED | — |
| Central Nervous System Complication | — | UNRESOLVED | — |
| Central Nervous System Infections | — | UNRESOLVED | — |
| Infection | — | UNRESOLVED | — |
| Infectious Disease of Nervous System | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Case group
- description
- HSCT recipients who developed a CNS disorder after HSCT
- label
- Control group
- description
- HSCT recipients whom did not develop a CNS disorder
Primary outcomes (4)
- measure
- Clinical characteristics of infectious and non-infectious CNS disorders following allogeneic or autologous HSCT
- timeFrame
- 32 months
- description
- Clinical characteristics to be analysed: * Recipient/donor sex * Recipient/donor age (at HSCT) * Primary diagnosis * Status of the primary disease at the time of HSCT - remission (partial or complete) /relapse /relapse including CNS involvement/progression, stable disease, unknown) * Prior CNS radiotherapy * Prior intrathecal (antineoplastic) treatment * Prior (antineoplastic) treatment (especially 'novel drugs´) * Pre-existing medical conditions * Recipient/donor serostatus of CMV, EBV, HHV-6, HSV, VZV, Toxoplasma spp. * Type of transplant (allogeneic vs. autologous) * Type of donor (MRD vs. haploidentical donor vs. other donor type) * Stem cell source (CB vs. BM vs. PB) * Type of conditioning (RIC vs MAC) * TCD (yes vs. no), ATG (yes vs. no), alemtuzumab (yes vs. no) * Acute and chronic GvHD (at day 0, including grade) * ECOG performance status at different time points * Concomitant infections * Selected peripheral blood parameters
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: Case group: * received allogeneic or autologous HSCT between January 1st, 2021 and December 31st, 2022 * develop an infectious (any CTCAE grade) or relevant (CTCAE \>1°) non-infectious CNS disorder after HSCT in this period. Control group: * received allogeneic or autologous HSCT between January 1st, 2021 and February 28th, 2023 * who survive and do not develop a CNS disorder until the inclusion time point (day 0, defined as the same delay between transplantation and CNS disorder onset of the corresponding case) Exclusion Criteria: * Patients with missing essential Med-A data * Patients not giving informed consent to report data to EBMT prior to initiation of transplant procedures
References
Publications (1)
- DERIVEDSchmidt-Hieber M, Ljungman P, Gilbert P, Knelange N, Drozd-Sokolowska J, Basak G, Einsele H, Tridello G, Abdeljelil NB, Kulagin A, Balaguer-Rosello A, Metafuni E, Faraci M, Gozdzik J, Martino R, Raiola AM, Xhaard A, Kuskonmaz B, Biffi A, Czyzewski K, Gabriel MA, Martinez-Lopez J, Zaidman I, Schlegel PG, Gruhn B, Krivan G, Vicent MG, Mikulska M, Peric Z, Averbuch D, Styczynski J, Penack O, Camara R. Central nervous system disorders following haematopoietic stem cell transplantation: a prospective case-control observational study from the Infectious Diseases Working Party and the Transplant Complications Working Party of EBMT. EClinicalMedicine. 2026 Feb 26;93:103792. doi: 10.1016/j.eclinm.2026.103792. eCollection 2026 Mar. PMID 41783087