Not recruiting

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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
Step 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
Step 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 trial?

12 criteria

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 trial?

15 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Akershus University Hospital
Lorenskog, Norway
Responsive
Amsterdam UMC
Amsterdam, The Netherlands
Responsive
Universitetssykehuset Nord-Norge HF
Tromsø, Norway

Trial locations

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Investigated drugs

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.

What is already known about the treatment

Alemtuzumab
A humanized monoclonal antibody administered through intravenous infusion, used in the treatment of relapsing-remitting multiple sclerosis. It works by targeting and destroying specific immune cells (CD52-positive cells) that are involved in the autoimmune attack on the nervous system, effectively resetting the immune system. This medication belongs to the class of selective immunosuppressants and has shown significant efficacy in reducing MS relapses and disability progression.
Cladribine
An oral medication taken in tablet form that is used to treat highly active relapsing multiple sclerosis. It functions as a synthetic purine nucleoside that interferes with DNA synthesis and repair in certain immune cells, resulting in a selective reduction of B and T lymphocytes. This medication belongs to the antineoplastic agents class and requires only a few days of treatment in each of two yearly cycles.
Ocrelizumab
A humanized monoclonal antibody administered via intravenous infusion every six months for the treatment of relapsing-remitting multiple sclerosis. It works by selectively targeting and depleting CD20-positive B cells, which play a key role in the immune system's attack on nerve cells in MS. This medication belongs to the class of selective immunosuppressants and has demonstrated effectiveness in reducing relapse rates and disability progression.

Investigated diseases

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.