Safety and Efficacy of Intrathecal Rituximab in Patients With Multiple Sclerosis

NCT05078177 | Unknown Phase 1

• 1 other identifier: intrathecal_rtx_ms
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Considering the accumulated data on the pathogenesis of multiple sclerosis, indicating a significant role of B cells in the progression of the disease, the use of monoclonal antibodies to CD20 antigen, administered intrathecally to achieve adequate B-lymphodepletion in the barrier tissues can increase the duration of the recurrence-free course of autoimmune diseases, suspend their progression, and also prevent clinical relapse when memory B cells are detected.

Conditions

Multiple Sclerosis

Keywords

Autoimmune Diseases; Rituximab

Outcome Measures

Primary Outcomes (1)

• Multiple sclerosis progression free survival

  To evaluate safety and effectiveness of intrathecal Rituximab in patients with refractory multiple sclerosis after AHSCT. Multiple sclerosis progression free survival

  365 days

Secondary Outcomes (10)

• Overall survival

  365 days

• To evaluate adverse effects after intrathecal Rituximab

  365 days

• Quality of life status 1

  365 days

• Quality of life status 2

  365 days

• Quality of life status 3

  365 days

Study Arms (1)

AHSCT + intrathecal Rituximab

EXPERIMENTAL

AHSCT with reduced intensity condition regimen (RIC). Lumbar puncture with intrathecal injection of 25 mg Rituximab will be performed once from about D+12 to D+14 AHSCT, depending on the duration of cytopenia.

Drug: Rituximab

Interventions

Rituximab DRUG

All patients receive AHSCT with RIC (Cyclophosphamide, Antithymocyte globulin/Rituximab). After resolution of cytopenia (approximately from about D+12 to D+14 AHSCT), patients will receive intrathecal Rituximab.

Also known as: Mabthera, Reditux, Acellbia

AHSCT + intrathecal Rituximab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65;
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Petersburg State Pavlov Medical University: lead

Study Sites (1)

First Pavlov State Medical University of St. Petersburg

Saint Petersburg, 197022, Russia

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Autoimmune Diseases

Interventions

Rituximab; Reditux

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ivan S Moiseev, MD, Ph.D

  Pavlov First Saint Petersburg State Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexey Yu Polushin, MD

CONTACT

+79118167559; alexpolushin@yandex.ru

Yury R Zalyalov, MD

CONTACT

+79112193127; yz21@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-director for science of R.M. Gorbacheva Memorial Institute of Hematology, Oncology and Transplantation

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 14, 2021
• Study Start: December 21, 2020
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2024
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

RU (1)