Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04737785
Registration number
NCT04737785
Ethics application status
Date submitted
14/01/2021
Date registered
4/02/2021
Titles & IDs
Public title
Central Nervous System Disorders Following Hematopoietic Stem Cell Transplantation
Query!
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
Query!
Secondary ID [1]
0
0
8414(0)136
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Central Nervous System Infections
0
0
Query!
Central Nervous System Complication
0
0
Query!
Infectious Disease of Nervous System
0
0
Query!
Blood Disease
0
0
Query!
Blood Cancer
0
0
Query!
Infection
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Studies of infection and infectious agents
Query!
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Infection
0
0
0
0
Query!
Sexually transmitted infections
Query!
Neurological
0
0
0
0
Query!
Other neurological disorders
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Acute leukaemia
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Chronic leukaemia
Query!
Blood
0
0
0
0
Query!
Haematological diseases
Query!
Intervention/exposure
Study type
Observational [Patient Registry]
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Clinical characteristics of infectious and non-infectious CNS disorders following allogeneic or autologous HSCT
Query!
Assessment method [1]
0
0
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
Query!
Timepoint [1]
0
0
32 months
Query!
Primary outcome [2]
0
0
Diagnostic characteristics of infectious and non-infectious CNS disorders following allogeneic or autologous HSCT
Query!
Assessment method [2]
0
0
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:
Query!
Timepoint [2]
0
0
32 months
Query!
Primary outcome [3]
0
0
Efficacy of CNS treatment for different types of CNS disorders
Query!
Assessment method [3]
0
0
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
Query!
Timepoint [3]
0
0
30 days
Query!
Primary outcome [4]
0
0
Survival
Query!
Assessment method [4]
0
0
alive or death, including date, cause of death, CNS disorder-related death vs. other death cause at the different study points
Query!
Timepoint [4]
0
0
32 months
Query!
Secondary outcome [1]
0
0
Incidence of infectious and non-infectious CNS disorders after HSCT
Query!
Assessment method [1]
0
0
To identify the Incidence of infectious and non-infectious CNS disorders after HSCT
Query!
Timepoint [1]
0
0
32 months
Query!
Secondary outcome [2]
0
0
Timing of infectious and non-infectious CNS disorders after HSCT
Query!
Assessment method [2]
0
0
To identify the timing of infectious and non-infectious CNS disorders after HSCT
Query!
Timepoint [2]
0
0
32 months
Query!
Secondary outcome [3]
0
0
Distribution of infectious and non-infectious CNS disorders after HSCT
Query!
Assessment method [3]
0
0
To identify the distribution of infectious and non-infectious CNS disorders after HSCT
Query!
Timepoint [3]
0
0
32 months
Query!
Secondary outcome [4]
0
0
Impact of development of CNS disorders on overall survival
Query!
Assessment method [4]
0
0
to identify the Impact of development of CNS disorders (yes/no) on overall survival (alive/dead) using a prospectively assessed matched control group without CNS
Query!
Timepoint [4]
0
0
32 months
Query!
Secondary outcome [5]
0
0
Risk factors for CNS disorders after allogeneic and autologous HSCT using a prospectively assessed matched control group
Query!
Assessment method [5]
0
0
Risk factors assed:
* Recipient/donor sex
* Recipient/donor age (at HSCT)
* Primary diagnosis
* Status of the primary disease at the time of HSCT
* 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
Query!
Timepoint [5]
0
0
32 months
Query!
Secondary outcome [6]
0
0
Efficacy of treatment for different types of CNS disorders
Query!
Assessment method [6]
0
0
Efficacy of treatment 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
Query!
Timepoint [6]
0
0
32 months
Query!
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)
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/01/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/08/2024
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
252
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
The Children's Hospital at Westmead - Westmead
Query!
Recruitment postcode(s) [1]
0
0
- Westmead
Query!
Recruitment outside Australia
Country [1]
0
0
Colombia
Query!
State/province [1]
0
0
Medellín
Query!
Country [2]
0
0
France
Query!
State/province [2]
0
0
Paris
Query!
Country [3]
0
0
Germany
Query!
State/province [3]
0
0
Cottbus
Query!
Country [4]
0
0
Germany
Query!
State/province [4]
0
0
Jena
Query!
Country [5]
0
0
Germany
Query!
State/province [5]
0
0
Wuerzburg
Query!
Country [6]
0
0
Germany
Query!
State/province [6]
0
0
Würzburg
Query!
Country [7]
0
0
Hungary
Query!
State/province [7]
0
0
Budapest
Query!
Country [8]
0
0
Israel
Query!
State/province [8]
0
0
Jarusalem
Query!
Country [9]
0
0
Italy
Query!
State/province [9]
0
0
Genova
Query!
Country [10]
0
0
Italy
Query!
State/province [10]
0
0
Padova
Query!
Country [11]
0
0
Italy
Query!
State/province [11]
0
0
Rome
Query!
Country [12]
0
0
Poland
Query!
State/province [12]
0
0
Bydgoszcz
Query!
Country [13]
0
0
Poland
Query!
State/province [13]
0
0
Kraków
Query!
Country [14]
0
0
Poland
Query!
State/province [14]
0
0
Warsaw
Query!
Country [15]
0
0
Russian Federation
Query!
State/province [15]
0
0
St. Petersburg
Query!
Country [16]
0
0
Spain
Query!
State/province [16]
0
0
Barcelona
Query!
Country [17]
0
0
Spain
Query!
State/province [17]
0
0
Madrid
Query!
Country [18]
0
0
Spain
Query!
State/province [18]
0
0
Valencia
Query!
Country [19]
0
0
Tunisia
Query!
State/province [19]
0
0
Tunis
Query!
Country [20]
0
0
Turkey
Query!
State/province [20]
0
0
Antalya
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
European Society for Blood and Marrow Transplantation
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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).
Query!
Trial website
https://clinicaltrials.gov/study/NCT04737785
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Martin Schmidt-Hieber, Dr
Query!
Address
0
0
Carl-Thiem-Klinikum, Clinic for Hematology and Oncology, Cottbus, Germany
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
Query!
No/undecided IPD sharing reason/comment
Query!
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 not provided in
https://clinicaltrials.gov/study/NCT04737785