NCT05832515RecruitingPhase 1
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.
Source: ClinicalTrials.gov · Last updated 7 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 4 Apr 2022
- Start date
- 1 Oct 2020
- Primary completion date
- 1 Oct 2025
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Diseases
- Multiple sclerosis
- NCT number
- NCT05832515
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 200
- From 1 Oct 2020 to the primary completion date, 1 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Somatic or psychiatric disorder making the patient unable to sign informed consent
Lab values
- Moderate or severe cardiac dysfunction, left ventricular ejection fraction \<50%
- 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
Other
- Moderate or severe decrease in pulmonary function, FEV1 \<70% or DLCO\<70% of predicted
- Respiratory distress \>grade I
- Requirement for vasopressor support at the time of enrollment
- Karnofsky performans status \<30%
- Pregnancy
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Pavlov State Medical University of St. Petersburg Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.