Study comparing stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab in patients with aggressive relapsing-remitting multiple sclerosis

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What is this study about?

This study focuses on patients with Multiple Sclerosis, specifically the relapsing-remitting form of the disease. The study compares different treatment approaches: autologous hematopoietic stem cell transplantation (a procedure using the patient’s own stem cells) versus three alternative medications – alemtuzumab, cladribine, or ocrelizumab. The purpose is to evaluate which treatment option is more effective and safe for patients with aggressive forms of relapsing-remitting Multiple Sclerosis.

Before the main treatment begins, patients receiving stem cell transplantation will be given cyclophosphamide and antithymocyte immunoglobulin as preparation medications. The medications used in the comparison group are given differently: Mavenclad (cladribine) is taken as tablets, Lemtrada (alemtuzumab) and Ocrevus (ocrelizumab) are given through infusion into a vein.

The study will monitor patients for five years to track their disease activity. This includes checking for new symptoms, performing brain scans to look for changes, and evaluating how well patients can perform daily activities. The study will also look at quality of life and ability to work.

1 Initial medication assignment

You will be randomly assigned to receive one of these treatments: alemtuzumab, cladribine, ocrelizumab, or stem cell transplantation.

The treatment assigned will determine your specific medication schedule and follow-up plan.

2 Treatment administration

If assigned to MAVENCLAD (cladribine): You will take tablets by mouth

If assigned to Thymoglobuline: You will receive the medication through an infusion into your vein

If assigned to Ocrevus (ocrelizumab): You will receive the medication as an infusion into your vein

If assigned to LEMTRADA (alemtuzumab): You will receive the medication as an infusion into your vein

3 Regular assessments

Your health will be monitored through regular medical examinations at weeks 24, 48, 96, 144, 192, and 240

Brain scans (MRI) will be performed to check for any changes

Physical ability tests will include walking and hand coordination exercises

Cognitive function tests will assess your memory and thinking abilities

Quality of life questionnaires will evaluate your daily activities and well-being

4 Long-term monitoring

The study will continue for 5 years (240 weeks)

Regular monitoring will track your progress and any changes in your condition

Final assessments will be conducted at the end of the study period

Who Can Join the Study?

  • Age must be between 18 and 50 years old, both men and women can participate
  • Women who can become pregnant and men with partners who can become pregnant must use highly effective birth control methods throughout the study. The birth control must continue for:
    • 4 months after alemtuzumab treatment
    • 6 months after cladribine treatment
    • 12 months after ocrelizumab treatment
  • Must have a confirmed diagnosis of relapsing-remitting multiple sclerosis according to McDonald criteria
  • Must have an EDSS score (a scale measuring disability level) between 0 and 5.5
  • Must have active disease in the past year despite current treatment, shown by:
    • At least one MS relapse (flare-up of symptoms)
    • AND either one or more active lesions on MRI with contrast
    • OR three or more new or growing lesions on MRI
  • Disease activity must have occurred at least 3 months after starting current MS treatment
  • Must be referred from a neurological department to a study site
  • Must be able to provide informed consent and willing to follow all study procedures and treatment plans

Who Cannot Join the Study?

  • Age below 18 or above 50 years
  • Pregnancy or breastfeeding
  • Active infections, including hepatitis B, hepatitis C, HIV, or tuberculosis
  • Significant heart, liver, or kidney problems
  • History of cancer within the past 5 years
  • Inability to provide informed consent
  • Current participation in other clinical trials
  • Severe mental health conditions that could interfere with study compliance
  • Known allergies to study medications
  • Previous treatment with stem cell transplantation
  • Severe respiratory problems
  • Uncontrolled diabetes or other serious metabolic disorders
  • Blood disorders that could affect treatment safety
  • Active autoimmune conditions other than multiple sclerosis
  • Use of prohibited medications within specified timeframe before study start

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Universitetssykehuset Nord-Norge HF Tromsø Norway
St. Olavs Hospital HF Trondheim Norway
Rigshospitalet Copenhagen Denmark
Aqjcjscsl Ucl Amsterdam The Netherlands
Aazvztjh Unrkstbucf Hmhkqgkk Lorenskog Norway
Uphrtey Undengdzvv Hskbfanv Uppsala Sweden
Hqdtl Bykqif Hj Bergen Norway

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
01.09.2024
Norway Norway
Not recruiting
01.09.2024
Sweden Sweden
Not recruiting
01.09.2024
The Netherlands The Netherlands
Not recruiting
01.09.2024

Trial locations

Alemtuzumab is a medication used to treat relapsing-remitting multiple sclerosis (MS). It works by targeting specific cells in the immune system that are involved in causing damage to the nervous system in MS patients.

Cladribine is a medication that helps reduce inflammation in multiple sclerosis by decreasing the number of certain white blood cells that contribute to the immune system attack on nerve cells.

Ocrelizumab is a medication that targets specific B-cells in the immune system. It helps reduce inflammation and nerve damage in people with relapsing-remitting multiple sclerosis.

Autologous Hematopoietic Stem Cell Transplantation (HSCT) is a therapeutic procedure where a patient’s own blood-forming stem cells are collected, stored, and then returned to their body after receiving treatments to suppress their immune system. This procedure aims to “reset” the immune system to stop it from attacking the nervous system.

Multiple Sclerosis – A chronic neurological condition where the immune system attacks the protective covering (myelin) of nerve fibers in the central nervous system. This damage disrupts communication between the brain and the rest of the body, causing a range of symptoms that can include problems with vision, balance, muscle control, and other basic body functions. The disease typically progresses in a pattern of relapses and remissions, where symptoms may come and go or gradually worsen over time. Multiple sclerosis can affect different people in different ways, with symptoms varying in type and severity. The condition most commonly appears between ages 20 and 40, and affects the brain, spinal cord, and optic nerves.

Trial ID:
2024-510630-40-00
NCT ID:
NCT03477500
Trial Phase:
Therapeutic confirmatory (Phase III)

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