RecruitingPhase 1NCT05832515

AHSCT With Fludarabine and Cyclophosphamide Based Conditioning Regimes in Patients With Multiple Sclerosis

Trial of the Efficacy and Safety of High-dose Immunosuppressive Therapy Based on Fludarabine and Cyclophosphamide-containing Conditioning Regimen Followed by Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Sclerosis.


Sponsor

St. Petersburg State Pavlov Medical University

Enrollment

200 participants

Start Date

Oct 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

One of the possible options for the treatment of MS at present is a high-dose immunosuppressive therapy followed by autologous hematopoietic stem cell transplantation (HIST-AHSCT), which is a highly effective treatment for patients with relapsing-remitting MS. This method of MS treatment was introduced in 1997. Significant complications and mortality associated with HIST-ATHSC is an obstacle to broad use of this method. The risk is even greater in patients with advanced disease, long duration of previous treatment and aggressive forms of MS. Despite toxicity certain progressive cases of MS are still an indication for HIST-autoHSCT. Most commonly used conditioning regimens for multiple sclerosis include high-dose cyclophosphamide. One of the options to reduce cyclophosphamide-related toxicity and dose is addition of fludarabine. Fludarabine is a cytostatic drug, an antimetabolite from the group of purine antagonists. It has a pronounced immunosuppressive activity and no overlapping toxicity with cyclophosphamide. The study will evaluate the safety and efficacy of this combination.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating a type of stem cell transplant (using stem cells from the patient's own body) as a treatment for people with multiple sclerosis (MS) whose disease is still progressing despite standard medications. The goal is to see whether this intensive treatment can "reset" the immune system and stop or slow MS progression. **You may be eligible if...** - You are between 18 and 65 years old - You have confirmed MS with a disability score between 1.0 and 6.5 on the standard MS scale (EDSS) - Your disease has been progressing or relapsing in the last 6 months despite MS medications - Your heart and lung function are good enough to tolerate the treatment **You may NOT be eligible if...** - You have significant heart or lung problems (low heart pumping ability or low lung capacity) - You have severe liver, kidney, or other organ problems - You have an active, uncontrolled infection - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGFludarabine Phosphate for Injection

Intravenous injection of fludarabine phosphate at a dose of 30 mg/m2 from day -5 to day -2 of immunoablative conditioning regimen.


Locations(1)

First Pavlov State Medical University of St. Petersburg

Saint Petersburg, Russia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05832515


Related Trials