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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04737785




Registration number
NCT04737785
Ethics application status
Date submitted
14/01/2021
Date registered
4/02/2021
Date last updated
21/08/2023

Titles & IDs
Public title
Central Nervous System Disorders Following Hematopoietic Stem Cell Transplantation
Scientific title
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
Secondary ID [1] 0 0
8414(0)136
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central Nervous System Infections 0 0
Central Nervous System Complication 0 0
Infectious Disease of Nervous System 0 0
Blood Disease 0 0
Blood Cancer 0 0
Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Neurological 0 0 0 0
Other neurological disorders
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Blood 0 0 0 0
Haematological diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Case group - HSCT recipients who developed a CNS disorder after HSCT

Control group - HSCT recipients whom did not develop a CNS disorder
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical characteristics of infectious and non-infectious CNS disorders following allogeneic or autologous HSCT
Timepoint [1] 0 0
32 months
Primary outcome [2] 0 0
Diagnostic characteristics of infectious and non-infectious CNS disorders following allogeneic or autologous HSCT
Timepoint [2] 0 0
32 months
Primary outcome [3] 0 0
Efficacy of CNS treatment for different types of CNS disorders
Timepoint [3] 0 0
30 days
Primary outcome [4] 0 0
Survival
Timepoint [4] 0 0
32 months
Secondary outcome [1] 0 0
Incidence of infectious and non-infectious CNS disorders after HSCT
Timepoint [1] 0 0
32 months
Secondary outcome [2] 0 0
Timing of infectious and non-infectious CNS disorders after HSCT
Timepoint [2] 0 0
32 months
Secondary outcome [3] 0 0
Distribution of infectious and non-infectious CNS disorders after HSCT
Timepoint [3] 0 0
32 months
Secondary outcome [4] 0 0
Impact of development of CNS disorders on overall survival
Timepoint [4] 0 0
32 months
Secondary outcome [5] 0 0
Risk factors for CNS disorders after allogeneic and autologous HSCT using a prospectively assessed matched control group
Timepoint [5] 0 0
32 months
Secondary outcome [6] 0 0
Efficacy of treatment for different types of CNS disorders
Timepoint [6] 0 0
32 months

Eligibility
Key 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)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2023
Actual
Sample size
Target
Accrual to date
Final
252
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
Colombia
State/province [1] 0 0
Medellín
Country [2] 0 0
France
State/province [2] 0 0
Paris
Country [3] 0 0
Germany
State/province [3] 0 0
Cottbus
Country [4] 0 0
Germany
State/province [4] 0 0
Jena
Country [5] 0 0
Germany
State/province [5] 0 0
Wuerzburg
Country [6] 0 0
Germany
State/province [6] 0 0
Würzburg
Country [7] 0 0
Hungary
State/province [7] 0 0
Budapest
Country [8] 0 0
Italy
State/province [8] 0 0
Genova
Country [9] 0 0
Italy
State/province [9] 0 0
Padova
Country [10] 0 0
Italy
State/province [10] 0 0
Rome
Country [11] 0 0
Poland
State/province [11] 0 0
Bydgoszcz
Country [12] 0 0
Poland
State/province [12] 0 0
Kraków
Country [13] 0 0
Poland
State/province [13] 0 0
Warsaw
Country [14] 0 0
Russian Federation
State/province [14] 0 0
St. Petersburg
Country [15] 0 0
Spain
State/province [15] 0 0
Barcelona
Country [16] 0 0
Spain
State/province [16] 0 0
Madrid
Country [17] 0 0
Spain
State/province [17] 0 0
Valencia
Country [18] 0 0
Tunisia
State/province [18] 0 0
Tunis
Country [19] 0 0
Turkey
State/province [19] 0 0
Antalya

Funding & Sponsors
Primary sponsor type
Other
Name
European Society for Blood and Marrow Transplantation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04737785
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Martin Schmidt-Hieber, Dr
Address 0 0
Carl-Thiem-Klinikum, Clinic for Hematology and Oncology, Cottbus, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT04737785