Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
NCT05832515

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

Led by St. Petersburg State Pavlov Medical University · Updated on 2024-05-07

200

Participants Needed

1

Research Sites

321 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-65
  • 1.0-6.5 points on the EDSS scale for MS
  • Any length of illness
  • Disease progression in the last 6 months despite first and second line drugs
  • Confirmed diagnosis of an autoimmune disease in previous treatment stages
  • Ineffectiveness, inaccessibility or intolerance to Disease-Modifying Therapies
  • Relapse after AHSCT
  • No severe other somatic diseases
  • Left ventricular ejection fraction greater than 50%
  • Karnofsky Performance Score greater than 30%
  • Ability to take oral medications
  • Life expectancy more than 1 month
  • Signed informed consent from patient or legal representatives
Not Eligible

You will not qualify if you...

  • Moderate or severe cardiac dysfunction with left ventricular ejection fraction less than 50%
  • Moderate or severe decrease in lung function (FEV1 less than 70% or DLCO less than 70% predicted)
  • Respiratory distress grade higher than I
  • Severe organ dysfunction (AST or ALT more than 5 times normal, bilirubin more than 1.5 times normal, creatinine more than 2 times normal)
  • Creatinine clearance less than 60 mL/min
  • Uncontrolled bacterial or fungal infection at enrollment
  • Need for vasopressor support at enrollment
  • Karnofsky performance status less than 30%
  • Pregnancy
  • Somatic or psychiatric disorder preventing informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

First Pavlov State Medical University of St. Petersburg

Saint Petersburg, Russia, 197022

Actively Recruiting

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Research Team

A

Alexey Yu Polushin

CONTACT

Y

Yury R Zalyalov

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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