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Observational Study in Multiple Sclerosis Patients Treated With Autologous Hematopoietic Stem Cell Transplantation

NCT04674280 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2020-12-21

No results posted yet for this study

Summary

Observational prospective , multi-center study

Primary objective : To gain further homogenous evidence for clinical efficacy of aHSCT in patients undergoing aHSCT for MS as primary indication.

Secondary objectives:

* Safety, tolerability and toxicity of aHSCT in MS
* Quality of life and long-term disability after aHSCT
* MRI outcome after aHSCT

Primary endpoint : Time to failure to maintain a NEDA status

Secondary endpoints:

* Overall survival
* Transplant related mortality
* MRI Assessment including lesions
* Treatment-related complications

. • Quality of life through the MS QL 54 standard assessment
* Improvement of disability

Inclusion criteria:

* Diagnosis of MS according to the 2010 revision McDonald's criteria
* Availability of a detailed clinical history about MS, including progression of disability and relapse rate in the previous 2 years, previous treatments administered
* Patients aged 18yrs or over at the time of the first aHSCT

Exclusion criteria:

* Lack of one of the above criteria
* Physical, mental, or social condition which could affect the patient from returning for follow-up visits
* Patients with cognitive impairments, who are unable to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are considered part of routine patient care.

Recruitment: 50 patients Recruitment period: 2 years starting from the inclusion of the 1st patient Follow-up duration: 2 years

Conditions

Interventions

PROCEDURE

aHSCT

Autologous haematopoietic stem cell transplantation

Sponsors & Collaborators

  • European Society for Blood and Marrow Transplantation

    lead NETWORK

Principal Investigators

  • Riccardo Saccardi, MD · European Society for Blood and Marrow Transplantation

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2025-01-31
Completion
2025-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04674280 on ClinicalTrials.gov