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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age 18-65; - 1.0-6.5 points on the EDSS scale (for MS); - Length of illness - any; - Disease progression during the last 6 months while taking drugs of 1st and 2nd lines; - An established and confirmed diagnosis of an autoimmune disease in the previous stages of treatment; - Ineffectiveness, inaccessibility or intolerance of Disease-Modifying Therapies; - Relapse after AHSCT.

- Absence of severe concomitant somatic pathology; - Left ventricular injection fraction > 50%; - Karnofsky Performance Score (KPS) > 30%; - The ability to take oral medications; - Life expectancy is more than 1 month; - Signed informed consent of the patient or legal representatives.

Exclusion Criteria:

- Moderate or severe cardiac dysfunction, left ventricular ejection fraction <50% - Moderate or severe decrease in pulmonary function, FEV1 <70% or DLCO<70% of predicted.

- Respiratory distress >grade I.

- Severe organ dysfunction: AST or ALT >5 upper normal limits, bilirubin >1.5 upper normal limits, creatinine >2 upper normal limits.

- Creatinine clearance < 60 mL/min.

- Uncontrolled bacterial or fungal infection at the time of enrollment.

- Requirement for vasopressor support at the time of enrollment.

- Karnofsky performans status <30% - Pregnancy.

- Somatic or psychiatric disorder making the patient unable to sign informed consent

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05832515
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	St. Petersburg State Pavlov Medical University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ivan S Moiseev
Principal Investigator Affiliation	Pavlov First Saint-Petersburg State Medical University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Russian Federation
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis

Arms & Interventions

Arms

Experimental: AHSCT: FluCy200

AHSCT with reduced intensity condition regimen (RIC): cyclophosphamide intravenously at a dose of 50 mg/kg/day from -5 to day -2 inclusive; fludarabine intravenously at a dose of 30 mg/m2 from -5 to day -2 inclusive. Immunotherapy: ATG - ATGAM intravenously 20 mg/kg from -3 to -1 or Thymoglobulin 2.5 mg/kg from -3 to -1 day. Also, within the framework of immunotherapy, instead of ATG, it is allowed to use anti-B-cell therapy - Rituximab 500 mg / m2 per day +12 AHSCT.

Interventions

Drug: - Fludarabine 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Saint Petersburg, Russian Federation

Status

Recruiting

Address

First Pavlov State Medical University of St. Petersburg

Saint Petersburg, , 197022

Site Contact

Alexey Yu Polushin, MD

[email protected]

+79118167559

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