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Ocrelizumab or Alemtuzumab Compared With Autologous Hematopoietic Stem Cell Transplantation in Multiple Sclerosis - a Phase-2 Randomised Controlled Trial

NCT04971005 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-03-16

No results posted yet for this study

Summary

A multicentre controlled phase II trial to compare the efficacy and safety of ocrelizumab or alemtuzumab and autologous Hematopoietic Stem Cell Transplantation (aHSCT). Active relapsing-remitting MS-Patients will be included and randomised to ocrelizumab or alemtuzumab versus aHSCT. Primary endpoint will be the time to treatment failure as assessed by failure of NEDA (no evidence of disease activity) as represented by: no expanded disability status scale (EDSS) progression, no relapse, no new T2 lesion and no Gd-enhancing lesion.

This trial offers the opportunity to gain further information about efficacy and safety of all treatments and will give new insights into the immunology of highly active RRMS.

Conditions

  • Relapsing-Remitting Multiple Sclerosis

Interventions

DRUG

Autologous Hematopoietic Stem Cell Transplantation

Autologous Hematopoietic Stem Cell Transplantation

DRUG

Ocrelizumab

600 mg every 6 months continuously

DRUG

Alemtuzumab

12 mg/day for 5 consecutive days and again after 365 days for 3 days

Sponsors & Collaborators

  • Neovii Biotech

    collaborator INDUSTRY

  • Clinical Trial Center North (CTC North GmbH & Co. KG)

    collaborator OTHER

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Nicolaus Kröger, Prof. Dr. · University Medical Center Hamburg-Eppendorf, Department of Stem Cell Transplantation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-08-27
Primary Completion
2022-02-04
Completion
2022-02-04

Countries

  • Germany

Study Locations

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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 NCT04971005 on ClinicalTrials.gov