NCT05832515 AHSCT With Fludarabine and Cyclophosphamide Based Conditioning Regimes in Patients With Multiple Sclerosis
| NCT ID | NCT05832515 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | St. Petersburg State Pavlov Medical University |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2020-10-01 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 200 participants in total. It began in 2020-10-01 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Ivan S Moiseev
PRINCIPAL INVESTIGATOR
Pavlov First Saint Petersburg State Medical University
Frequently Asked Questions
Who can join the NCT05832515 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05832515 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05832515 currently recruiting?
Yes, NCT05832515 is actively recruiting participants. Contact the research team at alexpolushin@yandex.ru for enrollment information.
Where is the NCT05832515 trial being conducted?
This trial is being conducted at Saint Petersburg, Russia.
Who is sponsoring the NCT05832515 clinical trial?
NCT05832515 is sponsored by St. Petersburg State Pavlov Medical University. The principal investigator is Ivan S Moiseev at Pavlov First Saint Petersburg State Medical University. The trial plans to enroll 200 participants.
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