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).
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical characteristics of infectious and non-infectious CNS disorders following allogeneic or autologous HSCT
Timeframe: 32 months
2
Diagnostic characteristics of infectious and non-infectious CNS disorders following allogeneic or autologous HSCT
Timeframe: 32 months
3
Efficacy of CNS treatment for different types of CNS disorders
Timeframe: 30 days
4
Survival
Timeframe: 32 months
Trial details
NCT IDNCT04737785
SponsorEuropean Society for Blood and Marrow Transplantation