Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation in the Netherlands

NCT06567197 | Recruiting

• 1 other identifier: NL83783.018.23
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to study the long-term effects of autologous hematopoietic stem cell transplantation (aHSCT) in people with highly active relapsing-remitting multiple sclerosis. The study will evaluate the following items:

1. 1.Disease activity
2. 2.Safety and tolerability of aHSCT
3. 3.Changes in the immune system

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (1)

• Treatment efficacy

  The proportion of patients with ne evidence of disease activity-3 (NEDA-3) as defined by: no clinical relapse, no disability progression, no radiological disease activity.

  2 years

Secondary Outcomes (20)

• Annual relapse rate

  2 years

• Time to first relapse

  2 years

• Confirmed disability progression (CDP)

  2 years

• Confirmed disability improvement (CDI)

  2 years

• Progression independent of relapse activity (PIRA)

  2 years

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with highly active relapsing-remitting multiple sclerosis are eligible for treatment with aHSCT in the Netherlands if they meet the criteria as defined by the Dutch National Health Care Institute.

You may qualify if:

• All patients approved for treatment with aHSCT in the Netherlands in accordance with the Dutch criteria for aHSCT treatment for RRMS

You may not qualify if:

• Contra-indications for treatment with aHSCT such as known hypersensitivity to the medication used for aHSCT
• Clinically relevant comorbidities preventing safe use of medication used for aHSCT
• Severe clinical depression
• Active addiction to drugs or alcohol
• Active infections such as but not limited to tuberculosis, cytomegalovirus, Epstein-Barr virus, herpes simplex, varicella zoster, viral hepatitis, toxoplasmosis, HIV or syphilis.
• Active malignancy or history of malignancy with the exception of local basal cell carcinoma or carcinoma in situ of the cervix

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• St. Antonius Hospital: collaborator

Study Sites (2)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

St. Antonius Hospital

Nieuwegein, Netherlands

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• J. Killestein, MSc, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rick Heijnen, MSc

CONTACT

+31627228507; r.m.heijnen@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: August 22, 2024
• Study Start: August 25, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

NL (2)