Sponsor study identifier
observational
252
12 countries
22
Study Start
January 1, 2021
Actual (reported)Primary Completion
June 30, 2023
Actual (reported)Study Completion
August 1, 2024
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2021
Actual (reported)January 14, 2021
Actual (reported)February 4, 2021
Actual (reported)June 30, 2023
Actual (reported)August 1, 2024
Actual (reported)Clinical characteristics of infectious and non-infectious CNS disorders following allogeneic or autologous HSCT
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
32 months
Diagnostic characteristics of infectious and non-infectious CNS disorders following allogeneic or autologous HSCT
Diagnostic characteristics analyzed: * Recipient´s age at onset of the CNS disorder (day 0) * Date of symptom onset of the CNS disorder * Type of symptoms (e.g. seizures, hemiplegia, paraplegia, paresis, psychosis, vomiting, confusion/altered consciousness, fever) * Date of diagnosis of the CNS disorder (e.g. CSF analysis) * Clinical diagnosis of CNS infection (e.g. encephalitis, meningitis, meningoencephalitis, myelitis, abscess, leukoencephalopathy) * Clinical diagnosis of non-infectious CNS disorder (e.g. metabolic/drug-induced disorder, posterior reversible encephalopathy syndrome, bleeding, thrombosis, ischemic stroke, CNS relapse of a underlying malignancy) * Time interval between HSCT and symptom onset * Time interval between symptom onset and diagnosis * Antimicrobial prophylaxis prior to onset of CNS disorder * Level of likelihood of the type of CNS disorder:
HSCT recipients who developed a CNS disorder after HSCT
HSCT recipients whom did not develop a CNS disorder
HSCT patients of any age with any underlying disease for which the transplant is given.
The Children's Hospital at Westmead
Westmead, Australia
Instituto de Cancerologia S.A
Medellín, Colombia
Hopital St. Louis
Paris, 75010, France
Carl-Thiem-Klinikum
Cottbus, Germany
Jena University Hospital
Jena, Germany
University Children's Hospital
Würzburg, Germany
Central Hospital of Southern Pest
Budapest, Hungary
Schmidt-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.
Martin Schmidt-Hieber, Dr
Carl-Thiem-Klinikum, Clinic for Hematology and Oncology, Cottbus, Germany
252 participants (actual enrollment reported by the registry).
First Submitted
January 14, 2021
First Posted
February 4, 2021
Study Start
January 1, 2021
Actual (reported)32 months
Efficacy of CNS treatment for different types of CNS disorders
Efficacy measured as: * CNS cured with neurological sequelae * CNS cured without neurological sequelae * CNS symptoms improved * CNS symptoms stabilized * deteriorating * death because of CNS disorder * death because of other cause Treatments analyzed: * Antimicrobials * Steroids * Surgical treatment * Reduction of immunosuppression * Other treatment Types of CNS disorders: * infectious * non-infectious
30 days
Survival
alive or death, including date, cause of death, CNS disorder-related death vs. other death cause at the different study points
32 months
Incidence of infectious and non-infectious CNS disorders after HSCT
32 months
Timing of infectious and non-infectious CNS disorders after HSCT
32 months
Distribution of infectious and non-infectious CNS disorders after HSCT
32 months
Impact of development of CNS disorders on overall survival
32 months
Risk factors for CNS disorders after allogeneic and autologous HSCT using a prospectively assessed matched control group
32 months
Contact the study team to confirm eligibility.
Hadassah University Hospital
Jarusalem, Israel
Institute G. Gaslini
Genova, Italy
Ospedale San Martino
Genova, Italy
Clinica di Oncoematologia Pediatrica
Padova, Italy
Universita Cattolica S. Cuore
Rome, Italy
University Hospital, Collegium Medicum UMK
Bydgoszcz, Poland
University Children's Hospital in Krakow
Krakow, Poland
The Medical University of Warsaw
Warsaw, Poland
Raisa Gorbacheva Research Institute for Oncology
Saint Petersburg, 197022, Russia
Hospital Santa Creu i Sant Pau
Barcelona, Spain
Hospital Univ. 12 de Octubre
Madrid, Spain
Niño Jesus Children's Hospital
Madrid, Spain
University Hospital La Fe
Valencia, Spain
Centre Ntl de greffe de MO de Tunis
Tunis, Tunisia
Hacettepe University Children's Hospital
Antalya, Turkey (Türkiye)
Primary Completion
June 30, 2023
Actual (reported)Study Completion
August 1, 2024
Actual (reported)Last Updated
August 27, 2024
Record last verified: 2024-08
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Source: ClinicalTrials.gov.
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